Clinical trial NCT00977522: A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia
Official title: A Randomized Phase 2, Double-Blind, Placebo-Controlled, Multi-Center Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia Treated With A Stable Dose Of A Second Generation Antipsychotic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: schizophrenia negative symptoms adjunctive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-15
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score
timeFrame: 12 weeks
measure: Vital Signs (Blood pressure, heart rate)
timeFrame: 15 weeks
measure: ECG
timeFrame: 15 weeks
measure: Safety laboratory assessments
timeFrame: 15 weeks
measure: Adverse events
timeFrame: 15 weeks
Secondary outcomes:
measure: Change from baseline in Quality of Life Scale (QLS)
timeFrame: 12 weeks
measure: Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores
timeFrame: 12 weeks
measure: Change from baseline in PANSS Total
timeFrame: 12 weeks
measure: Change from baseline in PANSS Positive Subscale
timeFrame: 12 weeks
measure: Change from baseline in PANSS General Subscale
timeFrame: 12 weeks
measure: Change from baseline in Clinical Global Impression Severity (CGI-S)
timeFrame: 12 weeks
measure: Clinical Global Impression Improvement (CGI-I) Total Score
timeFrame: 12 weeks
measure: Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified
timeFrame: 12 weeks
measure: Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale
timeFrame: 12 weeks
measure: Change from baseline in Global Assessment of Functioning
timeFrame: 12 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 15 weeks
measure: Pharmacokinetic assays
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Pfizer Investigational Site
state: California
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: Escondido
country: United States
facility: Pfizer Investigational Site
state: California
city: Garden Grove
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: National City
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Park Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Runnemede
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Fresh Meadows
country: United States
facility: Pfizer Investigational Site
state: New York
city: Holliswood
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Edmond
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bellaire
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: