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

A Phase 2 6-Week, Double-Blind, Placebo-Controlled, Multicenter Trial Of Varenicline Tartrate (CP-526,555) 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 Overview

• Status: Withdrawn
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: placebo; Drug: varenicline; Drug: varenicline

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: 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	Drug: varenicline; 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 Names: Chantix; Drug: varenicline; 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 Names: Chantix, Champix
ACTIVE_COMPARATOR: varenicline 1mg BID	Drug: varenicline; 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 Names: Chantix; Drug: varenicline; 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 Names: Chantix, Champix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ANTICIPATED): November 1, 2009
• Study Completion (ANTICIPATED): November 1, 2009

Study Registration Dates

• First Submitted: August 27, 2008
• First Submitted That Met QC Criteria: August 27, 2008
• First Posted (ESTIMATE): August 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2009
• Last Update Submitted That Met QC Criteria: February 20, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: schizophrenia, treatment, cognition
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Cognition Disorders; Schizophrenia; Cognitive Dysfunction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: A3051100