NCT00977522

Brief Summary

This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
1 country

37 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

September 14, 2009

Last Update Submit

February 2, 2012

Conditions

Schizophrenia

Keywords

schizophrenia negative symptoms adjunctive

Outcome Measures

Primary Outcomes (5)

  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score

    12 weeks

  • Vital Signs (Blood pressure, heart rate)

    15 weeks

  • ECG

    15 weeks

  • Safety laboratory assessments

    15 weeks

  • Adverse events

    15 weeks

Secondary Outcomes (12)

  • Change from baseline in Quality of Life Scale (QLS)

    12 weeks

  • Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores

    12 weeks

  • Change from baseline in PANSS Total

    12 weeks

  • Change from baseline in PANSS Positive Subscale

    12 weeks

  • Change from baseline in PANSS General Subscale

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

PF-03463275

EXPERIMENTAL
Drug: PF-03463275

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-03463275DRUG

30 mg Controlled Release tablet BID for 12 weeks

PF-03463275
PlaceboDRUG

Placebo tablet BID

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase.
  • Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months.
  • Evidence of stable symptomatology at least 3 months.

You may not qualify if:

  • Female subjects who are pregnant or breastfeeding.
  • Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results.
  • Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Pfizer Investigational Site

Cerritos, California, 90703, United States

Location

Pfizer Investigational Site

Chula Vista, California, 91910, United States

Location

Pfizer Investigational Site

Escondido, California, 92025, United States

Location

Pfizer Investigational Site

Garden Grove, California, 92845, United States

Location

Pfizer Investigational Site

Glendale, California, 91436, United States

Location

Pfizer Investigational Site

Long Beach, California, 90805, United States

Location

Pfizer Investigational Site

Long Beach, California, 90808, United States

Location

Pfizer Investigational Site

National City, California, 91950, United States

Location

Pfizer Investigational Site

Paramount, California, 90723, United States

Location

Pfizer Investigational Site

Torrance, California, 90502, United States

Location

Pfizer Investigational Site

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

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20036, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30308, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30328, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30333, United States

Location

Pfizer Investigational Site

Park Ridge, Illinois, 60068, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67207, United States

Location

Pfizer Investigational Site

Wichita, Kansas, 67211, United States

Location

Pfizer Investigational Site

Flowood, Mississippi, 39232, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89128, United States

Location

Pfizer Investigational Site

Runnemede, New Jersey, 08078, United States

Location

Pfizer Investigational Site

Toms River, New Jersey, 08755, United States

Location

Pfizer Investigational Site

Willingboro, New Jersey, 08046, United States

Location

Pfizer Investigational Site

Fresh Meadows, New York, 11366, United States

Location

Pfizer Investigational Site

Holliswood, New York, 11423, United States

Location

Pfizer Investigational Site

Staten Island, New York, 10304, United States

Location

Pfizer Investigational Site

Staten Island, New York, 10305, United States

Location

Pfizer Investigational Site

Edmond, Oklahoma, 73034, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73116, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Austin, Texas, 78731, United States

Location

Pfizer Investigational Site

Austin, Texas, 78754, United States

Location

Pfizer Investigational Site

Bellaire, Texas, 77401, United States

Location

Pfizer Investigational Site

Houston, Texas, 77008, United States

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

1-methyl-1H-imidazole-4-carboxylic acid (3-chloro-4-fluoro-benzyl)-(3-methyl-3-aza-bicyclo(3.1.0) hex-6-ylmethyl)amide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 15, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

US(37)