Clinical trial NCT01175135: An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia
Official title: A Phase 2, Multicenter, Double-blind, Randomized, Parallel Group, 4-week Inpatient Study To Evaluate The Safety And Efficacy Of Two Fixed Doses Of Pf-02545920 Compared To Placebo In The Treatment Of Acute Exacerbation Of Schizophrenia Using Risperidone As An Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia
acute exacerbation
inpatient
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia with acute exacerbation of illness
* The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant uncontrolled medical illness
* Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
* Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
timeFrame: Baseline, Week 4
measure: Proportion of Participants With Dystonia Adverse Events
timeFrame: Baseline up to end of study (7 to 10 days after administration of last dose of study medication)
Secondary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4
timeFrame: Baseline, Week 4
measure: Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Week 4
measure: Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4
timeFrame: Baseline, Week 4
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Score
timeFrame: Week 4
measure: Change From Baseline in Body Weight at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Abdominal Girth at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)
timeFrame: Baseline up to end of study (7 to 10 days after administration of last dose of study medication)
measure: Number of Participants With Clinically Significant Changes in Physical Examinations
timeFrame: Screening, Week 4
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Screening up to end of study (7 to 10 days after administration of last dose of study medication)
measure: Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC)
timeFrame: Day 1 up to Week 4
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin
timeFrame: Day 1 up to Week 4
measure: Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K & S Professional Research Services, LLC
state: Arkansas
city: Anaheim
country: United States
facility: Leisure Court Center
state: California
city: Escondido
country: United States
facility: Early Phase Investigational Center
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research Center of Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Long Beach
country: United States
facility: Ocean View Psychiatric Health Facility
state: California
city: Long Beach
country: United States
facility: Long Beach VA Healthcare System
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Paramount
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Paramount
country: United States
facility: LaPaz Geropsychiatric Center
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Torrance
country: United States
facility: Del Amo Hospital
state: California
city: Washington
country: United States
facility: Comprehensive Neuroscience, Incorporated
state: District of Columbia
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: Lakeside Behavioral Healthcare
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health Hospital
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Hoffman Estates
country: United States
facility: Chinmay K. Patel, D.O.
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Memorial Hospital
state: Louisiana
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Rockville
country: United States
facility: CBH Health, LLC
state: Maryland
city: Saint Louis
country: United States
facility: St. Louis Clinical Trials, LC
state: Missouri
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Willingboro
country: United States
facility: Lourdes Medical Center of Burlington County
state: New Jersey
city: Hollis
country: United States
facility: Comprehensive Neuroscience, Inc.
state: New York
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Austin
country: United States
facility: TexasNeuroRehab Center
state: Texas
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Houston
country: United States
facility: Bayou City Research, Ltd.
state: Texas
city: Houston
country: United States
facility: Behavioral Hospital - Bellaire
state: Texas
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Kirkland
country: United States
facility: Fairfax Hospital
state: Washington
city: Mannheim
country: Germany
facility: Zentralinstitut fuer Seelische Gesundheit
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Establishment "Dnipropetrovsk Regional Clinical Hospital n.a. Mechnikov"
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Establishment "Dnipropetrovsk Regional Clinical Psychiatric Hospital"
city: Kyiv
country: Ukraine
facility: Kyiv City Psychoneurological Hospital #2
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Psychoneurological Hospital #1
city: Lugansk
country: Ukraine
facility: Lugansk Regional Clinical Psychoneurological Hospital
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev
city: Stepanivka, Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital, Department #3
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Targum SD, Little JA, Lopez E, Demartinis N, Rapaport M, Ereshefsky L. Application of external review for subject selection in a schizophrenia trial. J Clin Psychopharmacol. 2012 Apr;32(2):825-6. doi: 10.1097/JCP.0b013e318248da90. No abstract available.