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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: placebo
Drug: varenicline
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: March 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Chantix
Active Comparator: varenicline 1mg BID 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743847

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00743847     History of Changes
Other Study ID Numbers: A3051100
Study First Received: August 27, 2008
Last Updated: February 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
schizophrenia, treatment, cognition

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014