Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo

Phase 2

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: PF-02545920

• Registration Number: NCT00570063
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-06
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2008-02-18
• Study Completion: 2008-02-18
• Disposition First Submitted: 2009-03-20
• Disposition First Submitted QC: 2009-09-25
• Disposition First Posted: 2009-09-30
• Status Verified: 2017-11
• Results First Submitted: 2017-11-20
• Results First Submitted QC: 2017-11-20
• Last Update Submitted: 2017-11-20
• Results First Posted: 2017-12-20
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Have a current diagnosis of schizophrenia.
2. Increase in symptoms over the past 2-4 weeks.
3. Willing to remain inpatients for the duration of the trial.

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Exclusion Criteria

1. Evidence or history of clinically significant medical problems.
2. Females of childbearing potential.
3. A primary psychiatric diagnosis other than schizophrenia.
4. A diagnosis of substance abuse or dependence in the last 6 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Matching placebo tablets taken twice a day by mouth for 21 days
1	PF-02545920	PF-02545920 15 mg tablets taken twice a day by mouth for 21 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Total Score	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at Day 21	Baseline (Day 1), Day 21	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score	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 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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score	Baseline (Day 1), Day 21	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score	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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score	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.
Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at Day 21	Baseline (Day 4), Day 21	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.
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at Day 21	Baseline (Day 1), Day 21	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.
Change From Baseline in Global Assessment of Functioning (GAF) Score at Day 21	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.

Trial Locations

Locations (9)

Glendale Adventist Medical Center; 🇺🇸 Glendale, California, United States

California Clinical Trials Medical Group, Inc.; 🇺🇸 Glendale, California, United States

Telecare-Cresta Loma; 🇺🇸 Lemon Grove, California, United States

LaPaz Geropsychiatric Center; 🇺🇸 Paramount, California, United States

Connecticut Mental Health Center-Yale University, Clinical Neuroscience Research Unit; 🇺🇸 New Haven, Connecticut, United States

CRI Worldwide, LLC; 🇺🇸 Willingboro, New Jersey, United States

IPS Research Company; 🇺🇸 Oklahoma City, Oklahoma, United States

California Clinical Trials Medical Group; 🇺🇸 San Diego, California, United States

St. Anthony Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States