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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00743847
• Other study ID #: A3051100
• Status: Withdrawn
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: February 20, 2009
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: February 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score		screening, wk -1, baseline, wk 1,3,6	No
Secondary	CNS-VS-M un-normed composite score		screening, wk-1,baseline,wk1,3,6	No
Secondary	CNS-VS-M un-normed and normed domain scores		screening, wk-1,baseline, wk1,3,6	No
Secondary	University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score		baseline, wk 1,3,6	No
Secondary	Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV)		baseline, wk6	No
Secondary	Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV)		wk 1,3,6	No
Secondary	Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures		weekly	Yes

External Links

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