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

Phase 2TerminatedNCT00570063

Pfizer35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia

Interventions

PF-02545920DRUG

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

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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. 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.

Locations (10)

California Clinical Trials Medical Group, Inc.

Glendale, California, United States

Glendale Adventist Medical Center

Glendale, California, United States

Telecare-Cresta Loma

Lemon Grove, California, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline (Day 1), Day 21

Secondary Outcomes

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Subscale Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Subscale Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: General Psychopathology Subscale Score

Data from ClinicalTrials.gov

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California Clinical Trials Medical Group

Paramount, California, United States

LaPaz Geropsychiatric Center

Paramount, California, United States

California Clinical Trials Medical Group

San Diego, 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

St. Anthony Hospital

Oklahoma City, Oklahoma, United States

IPS Research Company

Oklahoma City, Oklahoma, United States

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Positive Marder Factor Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Negative Marder Factor Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Disorganized Thought Marder Factor Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Hostility/Excitement Marder Factor Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Anxiety/Depression Marder Factor Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 21: Derived Brief Psychiatric Rating Scale (BPRS) Core Psychosis Total Score

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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) Score at 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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Clinical Global Impression Improvement Scale (CGI-I) Score at 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.

Time frame: Baseline (Day 4), Day 21

Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30) Subscale Scores at 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.

Time frame: Baseline (Day 1), Day 21

Change From Baseline in Global Assessment of Functioning (GAF) Score at 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.

Time frame: Baseline (Day 1), Day 21