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

Phase 2

Withdrawn

• Conditions: Schizophrenia
• Interventions: Drug: placebo; Drug: varenicline

• Registration Number: NCT00743847
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-29
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-20
• Last Update Posted: 2009-02-24
• Study Start: 2009-03
• Primary Completion: 2009-11
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
varenicline 0.5 mg BID	varenicline	-
varenicline 1mg BID	varenicline	-

Primary Outcome Measures

Name	Time	Method
CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score	screening, wk -1, baseline, wk 1,3,6

Secondary Outcome Measures

Name	Time	Method
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