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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00743847
First received: August 27, 2008
Last updated: February 20, 2009
Last verified: February 2009

August 27, 2008
February 20, 2009
March 2009
November 2009   (final data collection date for primary outcome measure)
CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score [ Time Frame: screening, wk -1, baseline, wk 1,3,6 ] [ Designated as safety issue: No ]
CNS Vital Signs Cogntion Battery (CNS-VS-M) normed composite score [ Time Frame: screening, wk -1, baseline, wk 1,3,6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00743847 on ClinicalTrials.gov Archive Site
  • CNS-VS-M un-normed composite score [ Time Frame: screening, wk-1,baseline,wk1,3,6 ] [ Designated as safety issue: No ]
  • CNS-VS-M un-normed and normed domain scores [ Time Frame: screening, wk-1,baseline, wk1,3,6 ] [ Designated as safety issue: No ]
  • University of California San Diego Performance Skills Assessment Brief (UPSA-B) total score [ Time Frame: baseline, wk 1,3,6 ] [ Designated as safety issue: No ]
  • Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV) [ Time Frame: baseline, wk6 ] [ Designated as safety issue: No ]
  • Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV) [ Time Frame: wk 1,3,6 ] [ Designated as safety issue: No ]
  • Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • CNS-VS-M un-normed composite score [ Time Frame: screening, wk-1,baseline,wk1,3,6 ] [ Designated as safety issue: No ]
  • CNS-VS-M un-normed and normed domain scores [ Time Frame: screening, wk-1,baseline, wk1,3,6 ] [ Designated as safety issue: No ]
  • Univeristy of California San Diego Performance Skills Assessment Brief (UPSA-B) total score [ Time Frame: baseline, wk 1,3,6 ] [ Designated as safety issue: No ]
  • Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV) [ Time Frame: baseline, wk6 ] [ Designated as safety issue: No ]
  • Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV) [ Time Frame: wk 1,3,6 ] [ Designated as safety issue: No ]
  • Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: placebo
    Subjects randomized to placebo will receive matching placebo and follow the titration schedule and dosing schedule of those randomized to varenicline.
  • 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 Name: 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 Name: Chantix, Champix
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: varenicline 0.5 mg BID
    Intervention: Drug: varenicline
  • Active Comparator: varenicline 1mg BID
    Intervention: Drug: varenicline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00743847
A3051100
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP