An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia

NCT01175135 | Completed Phase 2 Results DMC

• 2 other identifiers: A82410122010-020764-38
• Study Type: interventional
• Target: 259
• Locations: 3 countries
• Sites: 46

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.

Conditions

Schizophrenia

Keywords

schizophrenia; acute exacerbation; inpatient

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

  PANSS assesses 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). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

  Baseline, Week 4

• Proportion of Participants With Dystonia Adverse Events

  Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.

  Baseline up to end of study (7 to 10 days after administration of last dose of study medication)

Secondary Outcomes (17)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4

  Baseline, Week 4

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4

  Baseline, Week 4

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4

  Baseline, Week 4

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4

  Baseline, Week 4

• Clinical Global Impression - Improvement (CGI-I) Score

  Week 4

Study Arms (4)

PF-02545920 5 mg

EXPERIMENTAL

Drug: PF-02545920

PF-02545920 15 mg

EXPERIMENTAL

Drug: PF-02545920

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Risperidone 3 mg

ACTIVE COMPARATOR

Drug: Risperidone

Interventions

PF-02545920 DRUG

5 mg tablet every 12 hours for 28 days

PF-02545920 5 mg

Placebo DRUG

One tablet/capsule every 12 hours for 28 days

Placebo

Risperidone DRUG

3 mg capsule every 12 hours for 28 days

Also known as: Risperdal

Risperidone 3 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (46)

K & S Professional Research Services, LLC

Little Rock, Arkansas, 72201, United States

Location

Leisure Court Center

Anaheim, California, 92801, United States

Location

Early Phase Investigational Center

Escondido, California, 92025, United States

Location

Synergy Clinical Research Center of Escondido

Escondido, California, 92025, United States

Location

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

Ocean View Psychiatric Health Facility

Long Beach, California, 90806, United States

Location

Long Beach VA Healthcare System

Long Beach, California, 90822, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

California Clinical Trials Medical Group

Paramount, California, 90723, United States

Location

LaPaz Geropsychiatric Center

Paramount, California, 90723, United States

Location

Sharp Mesa Vista Hospital

San Diego, California, 92123, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Collaborative Neuroscience Network, Inc.

Torrance, California, 90502, United States

Location

Del Amo Hospital

Torrance, California, 90505, United States

Location

Comprehensive Neuroscience, Incorporated

Washington D.C., District of Columbia, 20016, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

Lakeside Behavioral Healthcare

Orlando, Florida, 32810, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Alexian Brothers Behavioral Health Hospital

Hoffman Estates, Illinois, 60169, United States

Location

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Chinmay K. Patel, D.O.

Hoffman Estates, Illinois, 60169, United States

Location

Lake Charles Memorial Hospital

Lake Charles, Louisiana, 70601, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

CBH Health, LLC

Rockville, Maryland, 20850, United States

Location

St. Louis Clinical Trials, LC

St Louis, Missouri, 63118, United States

Location

CRI Worldwide, LLC

Willingboro, New Jersey, 08046, United States

Location

Lourdes Medical Center of Burlington County

Willingboro, New Jersey, 08046, United States

Location

Comprehensive Neuroscience, Inc.

Hollis, New York, 11423, United States

Location

CRI Worldwide, LLC

Philadelphia, Pennsylvania, 19139, United States

Location

FutureSearch Trials

Austin, Texas, 78731, United States

Location

TexasNeuroRehab Center

Austin, Texas, 78745, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Bayou City Research, Ltd.

Houston, Texas, 77007, United States

Location

Behavioral Hospital - Bellaire

Houston, Texas, 77081, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Fairfax Hospital

Kirkland, Washington, 98034, United States

Location

Zentralinstitut fuer Seelische Gesundheit

Mannheim, 68159, Germany

Location

Municipal Establishment "Dnipropetrovsk Regional Clinical Hospital n.a. Mechnikov"

Dnipropetrovsk, 49005, Ukraine

Location

Municipal Establishment "Dnipropetrovsk Regional Clinical Psychiatric Hospital"

Dnipropetrovsk, 49115, Ukraine

Location

Kyiv City Psychoneurological Hospital #2

Kyiv, 02660, Ukraine

Location

Kyiv City Clinical Psychoneurological Hospital #1

Kyiv, 04080, Ukraine

Location

Lugansk Regional Clinical Psychoneurological Hospital

Luhansk, 91045, Ukraine

Location

Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev

Poltava, 36006, Ukraine

Location

Kherson Regional Psychiatric Hospital, Department #3

Stepanivka, Kherson, 73488, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 22388170 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Schizophrenia

Interventions

2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 4, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 22, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-04

Locations

US (38); UA (7); DE (1)