Study Of 323U66 SR In Major Depressive Disorder
2018年8月30日 更新者:GlaxoSmithKline
An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients With Depression
This study was designed to evaluate the efficacy and safety in major depressive disorder patients.
研究概览
研究类型
介入性
注册 (实际的)
234
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
-
-
-
- GSK Investigational Site
-
-
-
-
-
Fukuoka、日本、814-0180
- GSK Investigational Site
-
Hyogo、日本、651-1145
- GSK Investigational Site
-
Kanagawa、日本、228-0828
- GSK Investigational Site
-
Kumamoto、日本、861-8002
- GSK Investigational Site
-
Saitama、日本、332-0012
- GSK Investigational Site
-
Tokyo、日本、160-0023
- GSK Investigational Site
-
-
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 64年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Met DSM-IV-TR criteria for major depressive disorder for their current episode for at least 8 weeks prior to screening visit.
- Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
- Must have rating scores as outlined.
Exclusion criteria:
- Current or past history of seizure disorder or brain injury.
- Current or past history of anorexia or bulimia nervosa.
- History of manic episode.
- Past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder.
- Diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria.
- Pregnant, possibly pregnant or lactating.
- Must not be suicidal.
- Blood pressure of SBP>160mmHg, DBP>100mmHg.
- History or complication of cancer or malignant tumour.
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:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
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 |
---|---|---|
Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 in Observed Cases
大体时间:Baseline (Week 0) and Week 8
|
The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms.
The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed).
Total score ranges from 0-60.
A higher score indicates more depressive symptoms.
MADRS Response was defined as a reduction in MADRS score from Baseline.
Change from Baseline in the total score was calculated as the value at Week 8 minus the value at Baseline.
Baseline was defined as value at Week 0.
|
Baseline (Week 0) and Week 8
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change From Baseline in the MADRS Total Score at Week 52 in Observed Cases
大体时间:Baseline (Week 0) and Week 52
|
The MADRS is a semi-structured interview rating scale for depression that assesses 10 symptoms.
The scale is composed of 10 questions (1, apparent sadness; 2, reported sadness; 3, inner tension; 4, reduced sleep; 5, reduced appetite; 6, concentration difficulties; 7, lassitude; 8, inability to feel; 9, pessimistic thoughts; 10, suicidal thoughts) with a fixed 7 point scale (0, no depression; 60, severely depressed).
Total score ranges from 0-60.
A higher score indicates more depressive symptoms.
MADRS Response was defined as a reduction in MADRS score from Baseline.
Change from Baseline in the total score was calculated as the value at Week 52 minus the value at Baseline.
Baseline was defined as value at Week 0.
|
Baseline (Week 0) and Week 52
|
Change From Baseline in the Hamilton Depression Rating Scale (HAM-D; 17 Items) Total Score at Weeks 8 and 52 in Observed Cases
大体时间:Baseline (Week 0) and Week 8, 52
|
Each item was rated on either a 3-point scale (0 to 2; 8 questions) or a 5-point scale (0 to 4; 9 questions), with higher scores indicating greater symptom severity.
The total score was calculated by summing the individual response scores.
Total score ranged from 0 to 52.
The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization).
The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss.
Change from Baseline in the total score was calculated as the score at Week 8 and 52 minus the score at Baseline.
Baseline was defined as value at Week 0.
|
Baseline (Week 0) and Week 8, 52
|
Percentage of Participants Who Were Clinical Global Impression Global Improvement (CGI-I) Responders at Weeks 8 and 52 in Observed Cases
大体时间:Week 8, 52
|
The CGI-I scale was used to rate improvement in the participant's condition (benefits) since Baseline using the following 7-point scale: 1: very much improved, 2: much improved, 3: minimally improved, 4: not changed, 5: minimally worse, 6: much worse and 7: very much worse.
A responder was defined as "very much improved" or "much improved".
|
Week 8, 52
|
Change From Baseline in CGI Severity of Illness (CGI-SI) at Weeks 8 and 52 in Observed Cases
大体时间:Baseline (Week 0) and Week 8, 52
|
CGI-SI was assessed on an 8-grade scale: 0, not assessed; 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill and 7, among the most extremely ill.
Higher score indicated severely ill.
CGI-SI was assessed by the investigator.
The change from Baseline in CGI-SI score was calculated as the score at Weeks 8 and 52 minus the score at Baseline.
Baseline was defined as value at Week 0.
|
Baseline (Week 0) and Week 8, 52
|
Change From Baseline in the Sheehan Disability Scale (SDISS) Total Score at Weeks 8 and 52 in Observed Cases
大体时间:Baseline (Week 0) and Week 8, 52
|
SDISS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms.
The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale.
To get a total score, 3 individual scores were added and the total score ranged from "0 = unimpaired" to "30 = highly impaired".
Higher scores indicate worsening.
The change from Baseline in SDISS total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline.
Baseline was defined as value at Week 0.
|
Baseline (Week 0) and Week 8, 52
|
Change From Baseline in the Motivation Energy Inventory Short Form (MEI-SF) Total Score at Weeks 8 and 52 in Observed Cases
大体时间:Baseline (Week 0) and Week 8, 52
|
The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy and social motivation.
Minimal clinically important differences were estimated as 0.5 standard deviations or 7.5 points.
All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels and items were reverse-scored as necessary such that higher scores represent higher health-related quality of life (HRQoL) total score ranges from 0 to 108 points.
Recall period was past week prior to administration.
The change from Baseline in MEI-SF total score was calculated as the score at Weeks 8 and 52 minus the score at Baseline.
Baseline was defined as value at Week 0.
|
Baseline (Week 0) and Week 8, 52
|
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。
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)
2004年12月1日
初级完成 (实际的)
2007年5月28日
研究完成 (实际的)
2007年5月28日
研究注册日期
首次提交
2005年8月24日
首先提交符合 QC 标准的
2005年8月24日
首次发布 (估计)
2005年8月26日
研究记录更新
最后更新发布 (实际的)
2019年2月1日
上次提交的符合 QC 标准的更新
2018年8月30日
最后验证
2018年8月1日
更多信息
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.
抑郁症的临床试验
-
Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
-
Dren BioNovotech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 | LGLL - 大颗粒淋巴细胞白血病 | 原发性皮肤 T 细胞淋巴瘤 - 类别 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | 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 | 胃肠道惰性慢性淋巴增生性疾病 (CLPD)(CD8+ 或 NK 衍生) | 上面未列出的其他 CD8+/NK 细胞驱动的淋巴瘤美国, 澳大利亚, 法国, 西班牙
-
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
bupropion hydrochloride的临床试验
-
M.D. Anderson Cancer Center撤销转移性肺非小细胞癌 | IVA 期肺癌 AJCC v8 | IVB 期肺癌 AJCC v8 | IV 期肺癌 AJCC v8
-
Washington University School of MedicineGenentech, Inc.终止
-
Mayo Clinic完全的转移性结直肠腺癌 | 转移性结肠腺癌 | 转移性结直肠癌 | 转移性直肠腺癌 | IV 期结直肠癌 AJCC v8 | IVA 期结直肠癌 AJCC v8 | IVB 期结直肠癌 AJCC v8 | IVC 期结直肠癌 AJCC v8 | 转移性微卫星稳定性结直肠癌 | 转移性微卫星稳定性结肠癌 | 微卫星稳定性直肠癌美国
-
City of Hope Medical CenterNational Cancer Institute (NCI)完全的IV 期结直肠癌 AJCC v7 | IVA 期结直肠癌 AJCC v7 | IVB 期结直肠癌 AJCC v7 | 转移性结直肠癌 | III 期结肠癌 AJCC v7 | III 期直肠癌 AJCC v7 | IIIA 期结肠癌 AJCC v7 | IIIA 期直肠癌 AJCC v7 | IIIB 期结肠癌 AJCC v7 | IIIB 期直肠癌 AJCC v7 | IIIC 期结肠癌 AJCC v7 | IIIC 期直肠癌 AJCC v7 | IV 期结肠癌 AJCC v7 | IV 期直肠癌 AJCC v7 | IVA 期结肠癌 AJCC v7 | IVA 期直肠癌 AJCC v7 | IVB 期结肠癌 AJCC v7 | IVB 期直肠癌 AJCC v7 | III 期结直肠癌... 及其他条件美国
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)主动,不招人IV 期结直肠癌 AJCC v8 | IVA 期结直肠癌 AJCC v8 | IVB 期结直肠癌 AJCC v8 | IVC 期结直肠癌 AJCC v8 | III 期结直肠癌 AJCC v8 | IIIA 期结直肠癌 AJCC v8 | IIIB 期结直肠癌 AJCC v8 | IIIC 期结直肠癌 AJCC v8 | 难治性结直肠癌美国