- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570063
Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
November 20, 2017 updated by: Pfizer
A Phase 2, Multicenter, Double-blind, Randomized, Fixed Dose, Parallel Group, 3-week Inpatient Treatment Study To Evaluate The Safety, Efficacy And Pharmacokinetics Of Pf-02545920 Compared With Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia
To assess the efficacy and safety of an investigational compound PF-02545920 for the treatment of schizophrenia.
PF-02545920 will be more effective than placebo in reducing symptoms associated with schizophrenia.
Study Overview
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Glendale, California, United States, 91206
- Glendale Adventist Medical Center
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Glendale, California, United States, 91206
- California Clinical Trials Medical Group, Inc.
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Lemon Grove, California, United States, 91945
- Telecare-Cresta Loma
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Paramount, California, United States, 90723
- California Clinical Trials Medical Group
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Paramount, California, United States, 90723
- LaPaz Geropsychiatric Center
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San Diego, California, United States, 92123
- California Clinical Trials Medical Group
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Connecticut
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New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center-Yale University, Clinical Neuroscience Research Unit
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New Jersey
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Willingboro, New Jersey, United States, 08046
- CRI Worldwide, LLC
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- IPS Research Company
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Oklahoma City, Oklahoma, United States, 73101
- St. Anthony Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a current diagnosis of schizophrenia.
- Increase in symptoms over the past 2-4 weeks.
- Willing to remain inpatients for the duration of the trial.
Exclusion Criteria:
- Evidence or history of clinically significant medical problems.
- Females of childbearing potential.
- A primary psychiatric diagnosis other than schizophrenia.
- A diagnosis of substance abuse or dependence in the last 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
PF-02545920 15 mg tablets taken twice a day by mouth for 21 days
|
Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days
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Placebo Comparator: 2
Matching placebo tablets taken twice a day by mouth for 21 days
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Participants are assigned to 15 mg oral tablets twice a day of PF-02545920 or placebo in parallel for the duration of the study which is 21 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia.
The scale consists of 30 items.
Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe).
PANSS total score is the sum of the 30 items and ranges from 30 to 210; where higher score indicates greater severity of symptoms.
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Baseline (Day 1), Day 21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia.
PANSS positive subscale assesses the positive symptoms associated with schizophrenia as delusions, conceptual disorganization, and hallucinatory behavior.
It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe).
PANSS positive subscale is the sum of 7 items and ranges from 7 to 49; where higher score indicates greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia.
PANSS negative subscale assesses negative symptoms associated with schizophrenia as blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal.
It consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe).
PANSS negative subscale score is the sum of 7 items and ranges from 7 to 49, where higher score indicates greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS is a clinician-rated instrument for assessing the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia.
PANSS general psychopathology subscale score assesses general psychopathology symptoms associated with schizophrenia as somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance.
It consists of 16 items and each item is rated on a scale from 1 (symptoms absent) to 7 (extreme psychopathology).
PANSS general psychopathology subscale score is the sum of 16 items and ranges from 16 to 112; where higher scores indicates greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia.
PANSS positive Marder factor score consists of 8 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe).
PANSS positive Marder factor score is the sum of 8 items and ranges from 8 to 56; where higher score indicating greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia.
PANSS negative Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe).
PANSS negative Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia.
PANSS disorganized thought Marder factor score consists of 7 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe).
PANSS disorganized thought Marder factor score is the sum of 7 items and ranges from 7 to 49; where higher score indicating greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score
Time Frame: Baseline (Day 1), Day 21
|
PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia.
PANSS hostility/excitement Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe).
PANSS hostility/excitement Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score
Time Frame: Baseline (Day 1), Day 21
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PANSS subscales based on Marder factors assess negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor associated with schizophrenia.
PANSS anxiety/depression Marder factor score consists of 4 items and each item is rated on a scale from 1 (symptoms not present) to 7 (symptoms extremely severe).
PANSS anxiety/depression Marder factor score is the sum of 4 items and ranges from 4 to 28; where higher score indicating greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score
Time Frame: Baseline (Day 1), Day 21
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BPRS is a clinician-rated instrument for assessing conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content associated with schizophrenia.
The scale consists of 18 items.
Each item is rated on a scale from 0 (symptom not present) to 6 (symptoms extremely severe).
BPRS core psychosis total score is the sum of 18 items and ranges from 0 to 108; where higher score indicates greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21
Time Frame: Baseline (Day 1), Day 21
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CGI-S is a 7-point clinician-rated scale for assessing the global severity of schizophrenia.
Score range: 1 (normal - not ill at all) to 7 (most extreme illness).
Higher score indicating greater degree of illness.
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Baseline (Day 1), Day 21
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Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21
Time Frame: Baseline (Day 4), Day 21
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CGI-improvement is a 7-point clinician-rated scale for assessing the global improvement of schizophrenia ranging from 1 (very much improved) to 7 (very much worse).
Higher score indicating less improvement.
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Baseline (Day 4), Day 21
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Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21
Time Frame: Baseline (Day 1), Day 21
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NOSIE is an inpatient treatment staff-administered questionnaire.
It consists of 30 items: 26 items divided into 6 subscales and 4 individual items.
Each item is rated on a 5-point scale (0= never to 4= always), to assess functional ability of participants.
6 subscales: irritability (sum of 5 items: score range 0 to 20), manifest psychosis (sum of 4 items: score range 0 to 16), personal neatness (sum of 4 items: score range 0 to 16), retardation (sum of 3 items: score range 0 to 12), social competence (sum of 5 items: score range 0 to 20) and social interest (sum of 5 items: score range 0 to 20) and 4 individual items: cried (score range 0 to 4), refused to speak (score range 0 to 4), said felt blue or depressed (score range 0 to 4) and said he/she was no good (score range 0 to 4).
For each of the 6 subscales and 4 individual items: higher scores indicates irregular functional ability.
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Baseline (Day 1), Day 21
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Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21
Time Frame: Baseline (Day 1), Day 21
|
GAF is a single clinician-rated item to measure the severity of illness-related impairment in psychological, social and occupational functioning.
It is a 100 point rating scale, score range: 0= worst functioning to 99= superior functioning, where higher scores indicates better functioning.
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Baseline (Day 1), Day 21
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline (Day 1) up to Day 31
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 10 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non-serious adverse events.
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Baseline (Day 1) up to Day 31
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Number of Participants With Vital Signs of Potential Clinical Concern
Time Frame: Baseline (Day 1) up to Day 31
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Criteria for vital signs of potential clinical concern: pulse rate (supine/sitting position) less than (<) 40 or greater than (>) 120 beats per minute (bpm), pulse rate in standing position <40 or >140 bpm; systolic blood pressure (SBP) <90 millimeters of mercury (mm Hg) and greater than or equal to (>=) 30 mm Hg change (increase, decrease) from baseline in same posture; diastolic blood pressure (DBP) <50 mm Hg and >=20 mm Hg change (increase, decrease) from baseline in same posture.
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Baseline (Day 1) up to Day 31
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Number of Participants With Clinically Significant Physical and Neurological Examination Abnormalities
Time Frame: Baseline (Day 1) up to Day 31
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Analysis include general physical examination and assessment of head, ears, eyes, ocular fundi, nose, mouth, throat, neck, thyroid, lungs, heart, breasts, abdomen and musculoskeletal and neurological systems.
Clinical significance was based on the investigator's discretion.
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Baseline (Day 1) up to Day 31
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Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern
Time Frame: Baseline (Day 1) up to Day 31
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Criteria for ECG values for potential clinical concern: PR interval >=300 millisecond (msec), >=25 percent increase when baseline >200 msec, and >=50 percent increase when baseline less than or equal to (<=) 200 msec; QRS interval >=200 msec, >=25 percent increase when baseline >100 msec, and >=50 percent increase when baseline <=100 msec; QTcB interval (corrected QT interval using Bazett's formula) >=500 msec.
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Baseline (Day 1) up to Day 31
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Number of Participants With Laboratory Abnormalities
Time Frame: Baseline (Day 1) up to Day 31
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Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell (RBC) count: <0.8*lower limit of normal (LLN), platelet: <0.5*LLN or >1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN or >1.5*ULN, lymphocyte, neutrophil: <0.8*LLN or >1.2*ULN, basophil, eosinophil, monocyte: >1.2*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase: > 3.0*ULN, total protein, albumin: <0.8*LLN or>1.2*ULN;
blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; cholesterol (HDL <0.8*LLN, LDL >1.2*ULN); sodium <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN or >1.1*ULN, phosphate <0.8*LLN or >1.2*ULN; prolactin >1.1*ULN; glucose <0.6*LLN or >1.5*ULN, glycosylated hemoglobin >1.3*ULN, creatine kinase >2.0*ULN; urine (pH <4.5 or >8, glucose, ketone, protein, blood/Hgb >=1, RBC, WBC >=6).
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Baseline (Day 1) up to Day 31
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Number of Participants With Abnormal Prolactin Level
Time Frame: Baseline (Day 1) up to Day 21
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Number of participants with abnormal values (>1.1*
ULN) of prolactin level were reported.
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Baseline (Day 1) up to Day 21
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Number of Participants With Abnormal High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) Level
Time Frame: Baseline up to Day 21
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Number of participants with abnormal values of HDL level <0.8* LLN and LDL level >1.2*ULN were reported.
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Baseline up to Day 21
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Number of Participants With Abnormal Glycosylated Hemoglobin (HbA1c) Level
Time Frame: Baseline (Day 1) up to Day 21
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Number of participants with abnormal values (>1.3*
ULN) of HbA1c level were reported.
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Baseline (Day 1) up to Day 21
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Number of Participants With Abnormal Fasting Insulin Level
Time Frame: Baseline (Day 1) up to Day 21
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Fasting glucose level below 6 micro international unit per milliliter (mcIU/mL) or above 27 mcIU/mL were considered as abnormal.
Number of participants with abnormal values of fasting insulin level were reported.
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Baseline (Day 1) up to Day 21
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Change From Baseline in Body Weight at Day 21
Time Frame: Baseline (Day 1), Day 21
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Baseline (Day 1), Day 21
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Change From Baseline in Abdominal Girth at Day 21
Time Frame: Baseline (Day 1), Day 21
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Baseline (Day 1), Day 21
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Change From Baseline in Extrapyramidal Symptom Rating Scale - Abbreviated (ESRS-A) Score at Day 21
Time Frame: Baseline (Day 1), Day 21
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ESRS-A is an instrument used to assess extrapyramidal symptoms (including tremor and dystonic reactions).
It assesses 4 items: Parkinsonism, dystonia, dyskinesia, and akathisia.
Each item is scored on a 5-point severity scale ranging from 0 to 4, with higher score indicating greater severity of symptoms.
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Baseline (Day 1), Day 21
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Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 4, 7, 14 and 21
Time Frame: Baseline (Day 1), Day 4, 7, 14, 21
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SSS is a 7-point Likert scale which facilitates standardized observation of alertness and rates sleepiness, where 1= alert/wide awake, 2= able to concentrate, 3= not at full alertness, 4= not at peak and let down, 5= beginning to lose interest in remaining awake, 6= sleepiness, 7= sleep onset soon; lost struggle to remain awake.
Score ranging from 1 to 7, where higher score indicates more sleepiness.
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Baseline (Day 1), Day 4, 7, 14, 21
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Oral Clearance (CL/F) of PF-02545920
Time Frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
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Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
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Area Under the Concentration Time Curve (AUC) of PF-02545920
Time Frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
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AUC is a measure of the serum concentration of the drug over time.
It is used to characterize drug absorption.
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Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
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Steady State Average Concentration of PF-02545920 Over the Dosing Interval (Css,Avg)
Time Frame: Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
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Hour 0 (pre-morning dose) on Day 7, 14, 21; 20 minutes post-dose on Day 7; 1.5, 4.5 hours post-dose on Day 14 and 24 hours post-dose on Day 21
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2007
Primary Completion (Actual)
February 18, 2008
Study Completion (Actual)
February 18, 2008
Study Registration Dates
First Submitted
December 6, 2007
First Submitted That Met QC Criteria
December 7, 2007
First Posted (Estimate)
December 10, 2007
Study Record Updates
Last Update Posted (Actual)
December 20, 2017
Last Update Submitted That Met QC Criteria
November 20, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A8241006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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