Back to resultsA 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
placebo
varenicline
varenicline
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, treatment, cognition
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
placebo
varenicline 0.5 mg BID
varenicline 1mg BID
Arm Description
Outcomes
Primary Outcome Measures
CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score
Secondary Outcome Measures
CNS-VS-M un-normed composite score
CNS-VS-M un-normed and normed domain scores
University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score
Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV)
Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV)
Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00743847
Brief Title
A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Withdrawn
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, treatment, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
varenicline 0.5 mg BID
Arm Type
Active Comparator
Arm Title
varenicline 1mg BID
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects randomized to placebo will receive matching placebo and follow the titration schedule and dosing schedule of those randomized to varenicline.
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix, Champix
Intervention Description
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.
Primary Outcome Measure Information:
Title
CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score
Time Frame
screening, wk -1, baseline, wk 1,3,6
Secondary Outcome Measure Information:
Title
CNS-VS-M un-normed composite score
Time Frame
screening, wk-1,baseline,wk1,3,6
Title
CNS-VS-M un-normed and normed domain scores
Time Frame
screening, wk-1,baseline, wk1,3,6
Title
University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score
Time Frame
baseline, wk 1,3,6
Title
Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV)
Time Frame
baseline, wk6
Title
Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV)
Time Frame
wk 1,3,6
Title
Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures
Time Frame
weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051100&StudyName=A%206-Week%20Multicenter%20Trial%20Of%20Varenicline%20Tartrate%20For%20Cognitive%20Impairment%20In%20Subjects%20With%20Schizophrenia
Description
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A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia
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