A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 6-Week, Double-Blind, Placebo-Controlled, Multicenter Trial Of Varenicline Tartrate (CP-526,555) For Cognitive Impairment In Subjects With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: placebo
* Drug: varenicline
* Drug: varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a current diagnosis of schizophrenia Subjects must be on ongoing maintenance antipsychotic monotherapy or combination therapy with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone. Evidence of stable symptomatology ≥3 months (eg, no hospitalizations for schizophrenia, no increase in level of psychiatric care due to worsening of symptoms of schizophrenia). Exclusion Criteria: Subjects with a current DSM-IV axis I diagnosis other than schizophrenia. Current treatment with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine, or the use of adjunctive anticholinergic treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* Subjects randomized to placebo will receive matching placebo and follow the titration schedule and dosing schedule of those randomized to varenicline.<br>|
| Active Comparator: varenicline 0.5 mg BID<br> | Drug: varenicline<br>* 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.<br>* Other names: Chantix;|
| Active Comparator: varenicline 1mg BID<br> | Drug: varenicline<br>* 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.<br>* Other names: Chantix, Champix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score |  | screening, wk -1, baseline, wk 1,3,6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNS-VS-M un-normed composite score |  | screening, wk-1,baseline,wk1,3,6 | 
| CNS-VS-M un-normed and normed domain scores |  | screening, wk-1,baseline, wk1,3,6 | 
| University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score |  | baseline, wk 1,3,6 | 
| Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV) |  | baseline, wk6 | 
| Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV) |  | wk 1,3,6 | 
| Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures |  | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, treatment, cognition