Dose-response Study to Evaluate Safety, Efficacy, and Pharmacokinetics of PF-00217830 Compared With Placebo in Acute Exacerbation of Schizophrenia

April 16, 2012 updated by: Pfizer

A Phase 2, Multicenter, Double-Blind, Randomized, Fixed Dose, Parallel Group, 3-Week Inpatient Treatment Study To Evaluate The Dose-Response Relationship, Safety, Efficacy, And Pharmacokinetics Of PF-00217830 Compared With Placebo, Using Aripiprazole As A Positive Control, In The Treatment Of Acute Exacerbation Of Schizophrenia

The objective of this study is demonstrate efficacy and a dose-response in the treatment of acute exacerbation of schizophrenia in comparison to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Pune, India, 411 030
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
      • Mangalore, Karnataka, India, 575001
        • Pfizer Investigational Site
      • Udupi, Karnataka, India, 576 102
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 004
        • Pfizer Investigational Site
  • Russian Federation
      • Khotkovo, Russian Federation, 141371
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115522
        • Pfizer Investigational Site
      • St Petersburg, Russian Federation, 190121
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 194214
        • Pfizer Investigational Site
    • Leningrad region
      • Gatchina district, Leningrad region, Russian Federation, 188357
        • Pfizer Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49115
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 83037
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61068
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61018
        • Pfizer Investigational Site
      • Kiev, Ukraine, 02660
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 01030
        • Pfizer Investigational Site
      • Lugansk, Ukraine, 91045
        • Pfizer Investigational Site
    • Crimea
      • Simferopol, Crimea, Ukraine, 95006
        • Pfizer Investigational Site
  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Pfizer Investigational Site
      • Torrance, California, United States, 90502
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
    • Missouri
      • Bridgeton, Missouri, United States, 63044-2588
        • Pfizer Investigational Site
      • Florissant, Missouri, United States, 63033
        • Pfizer Investigational Site
      • St. Charles, Missouri, United States, 63304
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Key inclusion criteria include:

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

Exclusion Criteria:

  • Subjects with a current DSM-IV axis I diagnosis other than schizophrenia
  • Subjects who meet the DSM-IV criteria for psychoactive substance abuse and dependence
  • Subjects with a history of treatment resistant schizophrenia
  • Females of childbearing potential

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1
Drug: PF-00217830
PF-00217830 5 mg, oral capsule, once daily for 21 days
Drug: PF-00217830
PF-00217830 15 mg, oral capsule, once daily for 21 days
Drug: PF-00217830
PF-00217830 2 mg, oral capsule, once daily for 21 days
Experimental: A2
Drug: PF-00217830
PF-00217830 5 mg, oral capsule, once daily for 21 days
Drug: PF-00217830
PF-00217830 15 mg, oral capsule, once daily for 21 days
Drug: PF-00217830
PF-00217830 2 mg, oral capsule, once daily for 21 days
Experimental: A3
Drug: PF-00217830
PF-00217830 5 mg, oral capsule, once daily for 21 days
Drug: PF-00217830
PF-00217830 15 mg, oral capsule, once daily for 21 days
Drug: PF-00217830
PF-00217830 2 mg, oral capsule, once daily for 21 days
Placebo Comparator: A5
Other: Placebo
Placebo, oral capsule, once daily for 21 days
Active Comparator: A4
Drug: Aripiprazole
Aripiprazole 15 mg, oral capsule, once daily for 21 days
Other Names:
  • Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical laboratory (Screening, Days 1, 7, 14, 21 and Followup); Fasting insulin, HDL, LDL, HbA1c , prolactin, ACTH, and cortisol (Days 1 and 21).
Time Frame: 5 weeks
5 weeks
Physical examination (Screening, Days 1 and 21), neurological examination (Days 1 and 21), and ECG (Screening, Days 1, 7, 14, 20, 21 and Followup).
Time Frame: 5 weeks
5 weeks
Positive and Negative Symptom Scale (PANSS) total score.
Time Frame: Screening, Day 1, 3, 7, 14 and 21
Screening, Day 1, 3, 7, 14 and 21
Adverse events (Daily), weight (Screening, Days 1, and 21) and girth (Days 1 and 21), vital signs (Screening, Days 1, 3, 7, 14, 21 and Followup),
Time Frame: 5 weeks
5 weeks
Extrapyramidal Symptom Rating Scale (Screening, Days 1, 3, 7, 14 and 21) and the Stanford Sleepiness Scale (Days 1, 3, 7, 14 and 21).
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PANSS-derived Marder factor scores (positive, negative, disorganized thought, hostility/excitement, anxiety/depression)
Time Frame: Screening, Day 1, 3, 7, 14 and 21
Screening, Day 1, 3, 7, 14 and 21
PANSS positive, negative, and general psychopathology subscales
Time Frame: Screening, Day 1, 3, 7, 14 and 21
Screening, Day 1, 3, 7, 14 and 21
Clinical Global Impression Scale-S (severity), and Clinical Global Impression Scale-I (improvement)
Time Frame: Screening and Days 1, 3, 7, 14 and 21
Screening and Days 1, 3, 7, 14 and 21
NOSIE-30 subscales (irritability, manifest psychosis, personal neatness, retardation, social competence, and social interest) and the GAF.
Time Frame: Days 1 and 21
Days 1 and 21
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: Day 21
Day 21
Pharmacokinetics
Time Frame: Days 7, 14, 20, 21, before discharge and Followup
Days 7, 14, 20, 21, before discharge and Followup
PANSS-derived BPRS core psychosis items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content)
Time Frame: Screening and Days 1, 3, 7, 14 and 21
Screening and Days 1, 3, 7, 14 and 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 20, 2007

First Submitted That Met QC Criteria

December 20, 2007

First Posted (Estimate)

December 24, 2007

Study Record Updates

Last Update Posted (Estimate)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7251006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe