A Study of GW856553X For the Treatment of Depression
2017年7月14日 更新者：GlaxoSmithKline
A Randomized, Double Blind, Placebo Controlled Study to Explore the Antidepressant Properties of P38a Kinase Inhibitor GW856553X 15mg Compared to PBO in Subjects With Major Depressive Disorder Exhibiting Symptoms of Loss of Energy and Interest and Psychomotor Retardation, for a Six Week Treatment Period
GW856553 is a novel compound, currently in development for the treatment of Major Depressive Disorder (MDD), and other indications.
GW856553 inhibits a protein which is responsible for the production of some pro-inflammatory molecules, called cytokines.
Increased blood levels of these molecules were seen in populations of MDD patients and this was more apparent in subjects with severe symptoms, psychomotor retardation and loss of energy.
Aim of the present study is to assess whether GW856553, by inactivating this protein, is able to suppress the production of the cytokines, and ultimately relieving depression symptoms.
In this study GW856553 or placebo is given to MDD patients 7.5md twice daily for 6 weeks.
研究概览
详细说明
A randomised, double-blind, placebo-controlled study to explore the antidepressant properties of the P38a kinase inhibitor GW856553X 15mg compared to placebo in subjects with Major Depressive Disorder exhibiting symptoms of loss of energy and interest, and psychomotor retardation, for a six week treatment period.
研究类型
介入性
注册 (实际的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Moscow、俄罗斯联邦、115522
- GSK Investigational Site
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Moscow、俄罗斯联邦、119992
- GSK Investigational Site
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Moscow、俄罗斯联邦、107076
- GSK Investigational Site
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Moscow、俄罗斯联邦、123367
- GSK Investigational Site
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Nizhny Novgorod、俄罗斯联邦、603115
- GSK Investigational Site
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Smolensk、俄罗斯联邦、214 019
- GSK Investigational Site
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St-Petersburg、俄罗斯联邦
- GSK Investigational Site
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St.Petersburg、俄罗斯联邦、193167
- GSK Investigational Site
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Bangalore、印度、560034
- GSK Investigational Site
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Bangalore、印度、560029
- GSK Investigational Site
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Ludhiana、印度、141001
- GSK Investigational Site
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Manipal,、印度、576 104
- GSK Investigational Site
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Mumbai、印度、400010
- GSK Investigational Site
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Pune、印度、411004
- GSK Investigational Site
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Tartu、爱沙尼亚、50417
- GSK Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female = 18 years of age and < 60 years,
- routine laboratory results within normal ranges,
- Body Mass Index within the range 18.5-35.0 kg/m2 inclusive.
- Subject must have had at least one previous major depressive episode with a diagnosis of MDD in his/her history, and had a successful pharmacological treatment of that episode, and is currently experiencing a recurrence of MDD presently un-medicated.
- Subjects must met the diagnosis of an episode of Major Depressive Disorder in the past 12 weeks but not greater than 24 months.
Exclusion Criteria:
- The subject has any history of liver disease.
- The subject has significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial.
- The subject has a history of autoimmune diseases.
- The subject has any active infectious diseases, including active tuberculosis or a history of active tuberculosis.
- The subject has a history of malignancy, except for surgically cured basal cell carcinoma or females with cured cervical carcinoma (> 2 yrs prior).
- The subject has a history of HIV or other immunosuppressive disease.
- The subject has uncontrolled diabetes.
- The subject is pregnant or nursing.
- Subject has no contact with an adult on a daily basis (i.e., subjects who are not living with at least one other adult or subjects who do not have an adult who contacts them on a daily basis).
- Subject has initiated psychotherapy within three months prior to the Screening visit, or plans to initiate psychotherapy during the trial.
- Subject has received electroconvulsive therapy or transcranial magnetic stimulation or vagal nerve stimulation within the six months prior to the Screening.
- The subject is currently receiving a chronic biological or pharmacologic anti-inflammatory therapy; interferon therapy at any dose or did receive them within 6 months prior randomisation.
- Subjects who have donated a unit of blood within the previous month or intends to donate in the month after completing the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Arm 1
GW856553X 7.5mg BID for 6 weeks
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GW856553X 7.5mg BID for 6 weeks
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安慰剂比较：Placebo
Placebo to match, BID, 6 weeks
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Placebo to match GW856553X
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Randomization at Week 6 in Bech subscale (6-item of 17-item Hamilton depression rating [HAMD-17] scale) score
大体时间：Day 1 (Randomization, Week 0) and Week 6
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HAMD is an instrument for evaluating severity of symptoms of depression, was completed by the participant.
The instrument used in this study was the 17-item version (HAM-D17).
The Bech subscale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale.
Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4).
The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic).
The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general).
Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the post-Randomization (Week 6) value.
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Day 1 (Randomization, Week 0) and Week 6
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Change from Randomization (Week 0) at Week 6 in Inventory for Depressive Symptomatology-Clinician rated (IDS-C) scale total score
大体时间：Day 1 (Randomization, Week 0) and Week 6
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The IDS-C is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
In order to calculate the total score of IDS-C, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored.
The total score was obtained by adding the scores of 28 items of the 30 items.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the post-Randomization (Week 6) value.
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Day 1 (Randomization, Week 0) and Week 6
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Change from randomization (Week 0) at Week 6 in Quick Inventory of Depressive symptomatology 16 item self report (QIDS-SR16) scale total score
大体时间：Day 1 (Randomization, Week 0) and Week 6
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The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the participant.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
The total score was obtained by adding the scores of the items of depressed mood, decreased interest, fatigue, guilt, concentration, suicidal ideation, the highest score on any 1 of the 4 sleep items, the highest score on any 1 appetite/weight item and the highest score on either of the 2 psychomotor items.
Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the post-Randomization (Week 6) value.
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Day 1 (Randomization, Week 0) and Week 6
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Change from Randomization (Week 0) at Week 6 in the morning serum levels of the pro-inflammatory biomarkers
大体时间：Day 1 (Randomization, Week 0) and Week 6
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The pro-inflammatory biomarkers include the cytokines interleukin 6 (IL-6), IL-10, interleukin 2 receptor alpha (IL-2ra) and tumour necrosis factor alpha (TNFα).
Increased circulating levels of IL-6 and TNFα were consistently described in populations of participants suffering from MDD during the symptomatic episode.
The assessments were done at Week 0, Week 2 and Week 6. Serum samples for the assessment were taken at 8:00-9:00 h (before dosing and safety blood/urine sampling), 10:00-11:00 h and 12:00-13:00 h (+/-30 minutes).
Randomization value was defined as the assessment done on Day 1 (Week 0, pre-dose).
Change from Randomization was calculated by subtracting the Randomization value from the post-Randomization (Week 6) value.
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Day 1 (Randomization, Week 0) and Week 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with any Adverse events (AEs), Serious adverse events (SAEs) or Death
大体时间：Up to Follow-up (Up to 53 days)
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An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
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Up to Follow-up (Up to 53 days)
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Mean Suicidality Tracking Scale (STS) scores over period
大体时间：Week 0 up to Week 6
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The suicidality assessment throughout the study was made using the STS.
The STS is an 8-item checklist, developed from the MINI Tracking, Module C, designed to assess change in suicidality.
Individual items are rated on a 5-point scale from 0 (not at all) to 4 (extremely).
The total score ranged from 0-32, where 0 indicated absence of symptoms and higher score indicated greater severity of diseases.
Each item in the scale started with question of "yes" or "no", where the participants were asked to score themselves if the response was "yes".
This assessment was administered by a physician with adequate training in psychiatry.
The STS was administered at every Visit.
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Week 0 up to Week 6
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Number of participants with abnormal chemistry values
大体时间：Up to Follow-up (Up to 53 days)
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The assessments were done at Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 and Follow-up Visit.
The following laboratory parameters of clinical chemistry were analyzed: alkaline phosphatase, alanine transaminase (ALT), aspartate transaminase (AST), bilirubin (total, direct and indirect), total protein, blood urea nitrogen (BUN), albumin, glucose, creatinine, gamma-glutamyl transpeptidase (ϒ-GGT), sodium, potassium, chloride, calcium, phosphate, lactate dehydrogenase (LDH), creatine kinase (CK), C-reactive protein (high sensitivity assay), triglycerides, high-density lipoproteins (HDL), low-density lipoproteins (LDL) and total cholesterol.
Randomization value was the value at Week 0 (Day 1).
Only those parameters for which at least one abnormal value was reported are summarized.
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Up to Follow-up (Up to 53 days)
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Number of participants with abnormal hematology values
大体时间：Up to Follow-up (Up to 53 days)
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The assessments were done at Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 and Follow-up Visit.
The following laboratory parameters of clinical chemistry were analyzed: hemoglobin, hematocrit, red blood cells (RBC), reticulocytes, platelets, total white blood cells (WBC), total neutrophils, lymphocytes, monocytes, eosinophils, basophils, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean cell hemoglobin concentration (MCHC).
Randomization value was the value at Week 0 (Day 1).
Only those parameters for which at least one abnormal value was reported are summarized.
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Up to Follow-up (Up to 53 days)
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Number of participants with abnormal urinalysis results
大体时间：Up to Follow-up (Up to 53 days)
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The assessments were done at Week 0, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 and Follow-up Visit.
The urinalysis parameters of glucose, protein, blood and ketones by dipstick test, RBC, WBC and microscopy (if urine dipstick test was abnormal) for WBC, RBC, hyaline casts, granular casts and cellular casts were assessed.
The categories with results of few, moderate, many, 3+, 1-3, few (1-5) and trace is presented.
Randomization value was the value at Week 0 (Day 1).
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Up to Follow-up (Up to 53 days)
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Number of participants of vital signs outside range of Potential Clinical Importance (PCI)
大体时间：Up to Follow-up (Up to 53 days)
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Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP), done whilst the participant was in a sitting position for 5 minutes before each reading.
Criteria for vital sign values meeting PCI included: SBP < 85 and > 160 millimeters of mercury (mmHg) and increase or decrease from Baseline >= 20 and >= 40 mmHg; DBP < 45 and > 100 mmHg; HR < 40 and > 110 beats per minute (bpm).
Assessments were done at Week 0 (at pre-dose and at 3-4 h post-dose ), Week 1, Week 2 (at pre-dose and at 3-4 h post-dose), Week 3, Week 4 (at post-dose only ), Week 5, Week 6 (at pre-dose and at 3-4 h post-dose) and Follow-up Visit.
Randomization value was the value at Week 0 (Day 1).
Only those parameters for which at least one value of PCI was reported are summarized.
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Up to Follow-up (Up to 53 days)
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Number of participants of abnormal electrocardiogram (ECG) values
大体时间：Up to Follow-up (Up to 53 days)
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Full 12-lead ECGs was recorded whilst the participant was in supine position, using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QTc (b) intervals (Bazett's correction was applied to QTc measurements).
The measurement of ECGs were taken at Week 0, Week 2 and Week 6 at pre-dose around 8.00 h and at 12.00-13.00
h, at about 3-4 h post-dose.
At Week 4, measurement was taken post-dose only.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Abnormal ECG findings both not clinically significant (NCS) and clinically significant (CS) is categorized.
If the QTc(b) rised above 430 millisecond (msecs) for males and 450 msecs for females during the study, it was considered as abnormal.
Other abnormal ranges of PCI included : PR interval <110 and >220 msec; QRS interval <75 and >110 msec; absolute QTc interval >450 and <=499 msec.
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Up to Follow-up (Up to 53 days)
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Change from randomization (Week 0) at Week 1, 2, 3, 4 and 5 in Bech subscale (6-item of HAMD-17 scale) score
大体时间：Day 1 (Randomization, Week 0) up to Week 5
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The HAMD is an instrument for evaluating severity of symptoms of depression, was completed by the participant.
The instrument used in this study was the 17-item version (HAM-D17).
The Bech subscale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale.
Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4).
The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic).
The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general).
Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from randomization was calculated by subtracting the randomization value from the individual post-randomization (Week 1, 2, 3, 4 and 5) values.
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Day 1 (Randomization, Week 0) up to Week 5
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Change from Randomization (Week 0) at Week 1, 2, 3, 4 and 5 in IDS-C scale total score
大体时间：Day 1 (Randomization, Week 0) up to Week 5
|
The IDS-C is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
In order to calculate the total score of IDS-C, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored.
The total score was obtained by adding the scores of 28 items of the 30 items.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 1, 2, 3, 4 and 5) values.
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Day 1 (Randomization, Week 0) up to Week 5
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Change from randomization (Week 0) at Week 2 and 4 in QIDS-SR16 scale total score
大体时间：Day 1 (Randomization, Week 0) up to Week 4
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The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the participant.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
The total score was obtained by adding the scores of the items of depressed mood, decreased interest, fatigue, guilt, concentration, suicidal ideation, the highest score on any 1 of the 4 sleep items, the highest score on any 1 appetite/weight item and the highest score on either of the 2 psychomotor items.
Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 2 and 4) values.
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Day 1 (Randomization, Week 0) up to Week 4
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Change from randomization (Week 0) at Week 1, 2, 3, 4, 5 and 6 in HAMD-17 scale total score
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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HAMD-17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms).
The items of the HAMD-17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52, where 0 indicates absence of symptom and higher scores indicates more severe symptoms.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 1, 2, 3, 4, 5 and 6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Percentage of participants with Bech subscale (6-item HAMD-17) score responder and remitter at Week 6
大体时间：Week 6
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The HAMD is an instrument for evaluating severity of symptoms of depression, was completed by the participant.
The Bech subscale of the HAMD-17 is composed of 6 identified items out of the 17 items rated in HAMD-17 scale.
Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4).
The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic).
The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general).
Total score ranged from 0 to 22, with 0 indicating absence of symptoms and a higher score indicating greater severity of symptoms.
Responders were defined as participants with a reduction in total score of >=50% from randomization at Week 6 or study exit.
Remitters were defined as participants whose total score was <=4 at Week 6 or study exit.
Randomization value was defined as assessment done at Day 1 (Week 0).
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Week 6
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Percentage of participants with IDS-C scale total score responder and remitter at Week 6
大体时间：Week 6
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The IDS-C is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
In order to calculate the total score of IDS-C, the following procedures were used: either item 11 or 12 were scored; either item 13 or 14 were scored; if both items 11 and 12 (or 13 and 14) were scored, the highest of the items was scored.
The total score was obtained by adding the scores of 28 items of the 30 items.
Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.
Responders were defined as participants with a reduction in total score of >=50% from randomization at Week 6 or study exit.
Remitters were defined as participants whose total score was <=15 at Week 6 or study exit.
Randomization value was defined as assessment done at Day 1 (Week 0).
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Week 6
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Percentage of participants with QIDS-SR16 scale total score responder and remitter at Week 6
大体时间：Week 6
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The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the participant.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
The total score was obtained by adding the scores of the items of depressed mood, decreased interest, fatigue, guilt, concentration, suicidal ideation, the highest score on any 1 of the 4 sleep items, the highest score on any 1 appetite/weight item and the highest score on either of the 2 psychomotor items.
Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression.
Responders were defined as participants with a reduction in total score of >=50% from randomization at Week 6 or study exit.
Remitters were defined as participants whose total score was <=5 at Week 6 or study exit.
Randomization value was defined as assessment done at Day 1 (Week 0).
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Week 6
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Change from Randomization in Psychomotor Retardation subscale of the IDS-C scale over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The IDS-C is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms.
The Psychomotor Retardation subscale IDS-C is determined by a 5 item subscale of the IDS-C: item 5: mood (sad); item 15: concentration/decision making; item 20: energy/fatigability; item 23: psychomotor slowing; Item30: leaden paralysis/physical energy.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
The total score was obtained by adding the scores of the 5 items.
Total scores range from 0-15, with a score of 0 indicating no depression and higher score indicating more severe depression.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 1, 2, 3, 4, 5 and 6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in Psychomotor Retardation subscale of the QIDS-SR16 scale over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the participant.
The Psychomotor Retardation subscale QIDS-SR16 is determined by a 4 item subscale of the QIDS-SR16: depressed mood, decision making, energy, psychomotor slowing.
The items were rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
Total scores range from 0-12, with a score of 0 indicating no depression and higher score indicating more severe depression.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was planned to be calculated by subtracting the Randomization value from the individual post-Randomization (Week 1, 2, 3, 4, 5 and 6) values.
Data for this outcome measure was not collected and hence no result summary was produced during analysis.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in Psychomotor Retardation-Psychomotor Slowing item 23 of the IDS-C scale over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The IDS-C is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms.
The Psychomotor Retardation-Psychomotor Slowing item 23 of the IDS-C scale was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 1, 2, 3, 4, 5 and 6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in Psychomotor Retardation-Psychomotor Slowing item 15 of QIDS-SR16 scale over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the participant.
The Psychomotor Slowing item 15 of QIDS-SR16 scale was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 2, 4 and 6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Functional assessment of Fatigue and Sleepiness over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The Fatigue question is derived from the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) questionnaire.
The Sleepiness question is derived from the epidemiologic questionnaire used to identify Excessive Daytime Sleepiness (EDS) in a general population and in individual suffering from depression.
Questions were planned to be asked by the Investigator or designee for fatigue as "Did you feel fatigued or tired during the past 7 days?";
for sleepiness as "In the past 7 days, did you either feel sleepy during the day (but managed to stay awake) or have an irresistible sleep attack during the day, or both?"
The questions are scored on a 5-point scale of 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much.
The score ranged from 0-5, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
Data for this outcome measure was not collected and hence no result summary was produced during analysis.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in Visual Analogue Scale (VAS) of Fatigue/Tiredness and Sleepiness (at time of cytokine sampling) over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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Four different VAS (0-100 millimeter, minimum-maximum) for Sleepiness and Fatigue/Tiredness was scored before cytokine sampling at pre-dose, 2 h and 4 h post-dose.
VAS score for Sleepiness and Fatigue/Tiredness consist of following: item 1: alert (0=alert, 100=drowsy); item 2: sleepy (0=sleepy, 100=awake); item 3: strong (0=strong, 100=feeble); item 4: most tired ever felt (0=most tired ever felt, 100=less tired ever felt).
Fatigue/Tiredness was based on score of item 3 and 4 and sleepiness on score of item 1 and 2. All item scores do not move in same direction.
Score for item 1 and 3 ranged from 0-100, where 0=absence of symptom and higher score=greater severity of symptom.
Score for item 2 and 4 ranged from 0-100, where 0=most severe symptom and higher score=less severe symptom.
Randomization value defined as assessment done on Day 1 (Week 0, pre-dose).
Change from Randomization was calculated by subtracting Randomization value from individual post-Randomization (Week 0-6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in Fatigue-Energy item 20 of the IDS-C scale over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The IDS-C is a standardized 30-item, clinician rated scale to assess the severity of a participant's depressive symptoms.
The Fatigue-Energy item 20 of the IDS-C scale was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 1, 2, 3, 4, 5 and 6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in Energy/Fatigue item 14 of the QIDS-SR16 scale over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the participant.
The Energy/Fatigue item 14 of the QIDS-SR16 scale was rated on a 4-point scale of 0-3, where 0 indicated absence of symptom and higher score indicated greater severity of symptom.
Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 2, 4 and 6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in plasma cortisol over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The assessments were done at Randomization (Day1, pre-dose, 2 h and 4 h post dose), Week 2 (pre-dose, 2 h and 4 h post-dose) and Week 6 (pre-dose, 2 h and 4 h post-dose).
Randomization value was defined as the assessment done on Day 1 (Week 0, pre-dose).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 0 [2 h and 4 h post dose], Week 2 [pre-dose, 2 h and 4 h post-dose] and Week 6 [pre-dose, 2 h and 4 h post-dose]) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in serum TNFα/IL-10 ratio over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The assessments were done at Week 0, Week 2 and Week 6. Serum samples for the assessment were taken at 8:00-9:00 h (before dosing and safety blood/urine sampling), 10:00-11:00 h and 12:00-13:00 h (± 30 minutes).
Randomization value was defined as the assessment done on Day 1 (Week 0, pre-dose).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 0 [2 h and 4 h post-dose], Week 2 [pre-dose, 2 h and 4 h post-dose] and Week 6 [pre-dose, 2 h and 4 h post-dose]) values.
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Day 1 (Randomization, Week 0) up to Week 6
|
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Change from Randomization in high sensitivity C-reactive protein (hs-CRP) over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
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The assessments were done at Week 0, Week 2 and Week 6. Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 2 and Week 6) values.
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Day 1 (Randomization, Week 0) up to Week 6
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Change from Randomization in number of leukocytes over Week 6
大体时间：Day 1 (Randomization, Week 0) up to Week 6
|
The assessments were done at Week 0, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Randomization value was defined as the assessment done on Day 1 (Week 0).
Change from Randomization was calculated by subtracting the Randomization value from the individual post-Randomization (Week 1 to 6) values.
|
Day 1 (Randomization, Week 0) up to Week 6
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|
Plasma concentration of GW856553X and GSK198602
大体时间：Pre-dose and 4 h post-dose at Week 2 and Week 6
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Plasma concentration of GW856553X and of the metabolite GSK198602 was assessed during the treatment period.
Blood samples were collected at 8:00 h (before dosing) and 12:00-13:00 h (about 4 h after dosing) at Weeks 2 and 6 of the treatment period.
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Pre-dose and 4 h post-dose at Week 2 and Week 6
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|
Maximum plasma concentration (Cmax) of GW856553X and GSK198602
大体时间：Pre-dose and 4 h post-dose at Week 2 and Week 6
|
Plasma concentration of GW856553X and of the metabolite GSK198602 was assessed during the treatment period.
Blood samples were collected at 8:00 h (before dosing) and 12:00-13:00 h (about 4 h after dosing) at Weeks 2 and 6 of the treatment period.
The first occurrence of the maximum observed plasma concentration was planned to be determined directly from the raw concentration-time data.
The data for this outcome measure was not derived due to early termination.
|
Pre-dose and 4 h post-dose at Week 2 and Week 6
|
|
Median time to Cmax (tmax) and the terminal phase half-life (t1/2)
大体时间：Pre-dose and 4 h post-dose at Week 2 and Week 6
|
Plasma concentration of GW856553X and of the metabolite GSK198602 was assessed during the treatment period.
Blood samples were collected at 8:00 h (before dosing) and 12:00-13:00 h (about 4 h after dosing) at Weeks 2 and 6 of the treatment period.
The time at which Cmax observed was planned to be determined directly from the raw concentration-time data.
The apparent t1/2 was planned to be obtained as the ratio of ln2/λz, where λz is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data.
The data for this outcome measure was not derived due to early termination.
|
Pre-dose and 4 h post-dose at Week 2 and Week 6
|
|
The area under the plasma concentration-time curve (AUC)
大体时间：Pre-dose and 4 h post-dose at Week 2 and Week 6
|
Blood samples were collected at 8:00 h (before dosing) and 12:00-13:00 h (about 4 h after dosing) at Weeks 2 and 6 of the treatment period.
The AUC was planned to be assessed from time zero (pre-dose) extrapolated to infinite time (AUC0-infinity) and from time zero (pre-dose) to last time of quantifiable concentration within a participant across all treatments (AUC0-t).
AUC0-t was planned to be determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
The AUC0-infinity was planned to be calculated, where data permitted, as the sum of AUC0-t and Ct/z, where Ct is the observed plasma concentration obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant.
The data for this outcome measure was not derived due to early termination.
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Pre-dose and 4 h post-dose at Week 2 and Week 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年9月12日
初级完成 (实际的)
2008年6月25日
研究完成 (实际的)
2008年6月25日
研究注册日期
首次提交
2007年12月5日
首先提交符合 QC 标准的
2007年12月5日
首次发布 (估计)
2007年12月6日
研究记录更新
最后更新发布 (实际的)
2017年7月18日
上次提交的符合 QC 标准的更新
2017年7月14日
最后验证
2017年7月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
研究数据/文件
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个人参与者数据集
信息标识符：PKI108574信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
临床研究报告
信息标识符：PKI108574信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
研究协议
信息标识符：PKI108574信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
知情同意书
信息标识符：PKI108574信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
数据集规范
信息标识符：PKI108574信息评论：For additional information about this study please refer to the GSK Clinical Study Register
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
抑郁症，主要的临床试验
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Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
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Dren BioNovotech Health Holdings Pte. Ltd.招聘中侵袭性 NK 细胞白血病 | 肝脾T细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 单形性趋上皮性肠 T 细胞淋巴瘤 | 原发性皮肤 Gamma-Delta T 细胞淋巴瘤 | LGLL - 大颗粒淋巴细胞白血病 | 系统性 EBV1 T 细胞淋巴瘤，如果 CD8 阳性 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | 结外 NK/T 细胞淋巴瘤，鼻型 | 原发性皮肤CD8+侵略性表皮T细胞淋巴瘤 | 细胞毒性PTCL-NOS（CD8+或CD56+和细胞毒性标记） | 皮肤PTCL-NOS（CD8+或CD56+和细胞毒性标记）美国, 澳大利亚, 台湾, 法国, 西班牙, 意大利, 香港, 德国, 韩国
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Memorial Sloan Kettering Cancer Center招聘中蕈样肉芽肿 | 塞扎里综合症 | 血管免疫母细胞性T细胞淋巴瘤 | 肝脾T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阳性 | 结外 NK/T 细胞淋巴瘤，鼻型 | T细胞淋巴瘤 | 未特指的外周 T 细胞淋巴瘤 | 原发性皮肤间变性大细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阴性 | 单形性趋上皮性肠 T 细胞淋巴瘤 | T 细胞幼淋巴细胞白血病 | T 细胞大颗粒淋巴细胞白血病 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | NK细胞淋巴瘤 | 侵袭性 NK 细胞白血病 | 成人 T 细胞白血病/淋巴瘤 及其他条件美国