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

NCT00743847 | Withdrawn Phase 2 DMC

• 1 other identifier: A3051100
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

schizophrenia, treatment, cognition

Outcome Measures

Primary Outcomes (1)

• CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score

  screening, wk -1, baseline, wk 1,3,6

Secondary Outcomes (6)

• 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

Study Arms (3)

placebo

PLACEBO COMPARATOR

Drug: placebo

varenicline 0.5 mg BID

ACTIVE COMPARATOR

Drug: varenicline

varenicline 1mg BID

ACTIVE COMPARATOR

Drug: varenicline

Interventions

placebo DRUG

Subjects randomized to placebo will receive matching placebo and follow the titration schedule and dosing schedule of those randomized to varenicline.

placebo

varenicline DRUG

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.

Also known as: Chantix

varenicline 0.5 mg BID

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 24, 2009

Record last verified: 2009-02