A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia
The primary objective of this protocol is to assess the efficacy of two dose strengths of varenicline (0.5 mg BID and 1mg BID) as adjunctive treatment for cognitive impairment in symptomatically stable outpatient schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.
A secondary objective is to evaluate the safety and tolerability of two doses of varenicline in symptomatically stable schizophrenic subjects who are receiving treatment with atypical antipsychotic medications.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2 6-Week, Double-Blind, Placebo-Controlled, Multicenter Trial Of Varenicline Tartrate (CP-526,555) For Cognitive Impairment In Subjects With Schizophrenia|
- CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score [ Time Frame: screening, wk -1, baseline, wk 1,3,6 ]
- CNS-VS-M un-normed composite score [ Time Frame: screening, wk-1,baseline,wk1,3,6 ]
- CNS-VS-M un-normed and normed domain scores [ Time Frame: screening, wk-1,baseline, wk1,3,6 ]
- University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score [ Time Frame: baseline, wk 1,3,6 ]
- Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV) [ Time Frame: baseline, wk6 ]
- Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV) [ Time Frame: wk 1,3,6 ]
- Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures [ Time Frame: weekly ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Placebo Comparator: placebo||
Subjects randomized to placebo will receive matching placebo and follow the titration schedule and dosing schedule of those randomized to varenicline.
|Active Comparator: varenicline 0.5 mg BID||
Subjects randomized to the 0.5 mg arm will be titrated to the full dose during the first week in the following manner: 0.5mg QD x 7 days, then 0.5mg BID for the remainder of the 6 week trial.
Other Name: Chantix
|Active Comparator: varenicline 1mg BID||
Subjects randomized to the 1mg arm will be titrated to the full dose during the first week in the following manner: 0.5mg QD x 3 days, 0.5mg BID x 4 days, then 1mg BID for the remainder of the 6 week trial.
Other Name: Chantix, Champix
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743847
|Study Director:||Pfizer CT.gov Call Center||Pfizer|