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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01175135
First received: August 3, 2010
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: PF-02545920
Drug: Placebo
Drug: Risperidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) Total Score change from baseline [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Incidence rate of dystonia adverse events [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) subscales and derived scales change from baseline [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity Scale change from baseline [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement Scale [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Global Assessment of Function Scale change from baseline [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction Questionnaire for Medication [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • White blood cell count and absolute neutrophil count [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: Yes ]
  • Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: Yes ]
  • The Columbia Suicide Severity Rating Scale (C SSRS) [ Time Frame: Screening to Follow up visit ] [ Designated as safety issue: Yes ]

Enrollment: 259
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-02545920 5 mg Drug: PF-02545920
5 mg tablet every 12 hours for 28 days
Experimental: PF-02545920 15 mg Drug: PF-02545920
15 mg tablet every 12 hours for 28 days
Placebo Comparator: Placebo Drug: Placebo
One tablet/capsule every 12 hours for 28 days
Active Comparator: Risperidone 3 mg Drug: Risperidone
3 mg capsule every 12 hours for 28 days
Other Name: Risperdal

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175135

  Show 41 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01175135     History of Changes
Other Study ID Numbers: A8241012
Study First Received: August 3, 2010
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
schizophrenia
acute exacerbation
inpatient

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 29, 2014