Schizophrenia
Conditions
Keywords
schizophrenia, treatment, cognition
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.
Interventions
DRUGplacebo
Subjects randomized to placebo will receive matching placebo and follow the titration schedule and dosing schedule of those randomized to varenicline.
DRUGvarenicline
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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CNS Vital Signs Cognition Battery (CNS-VS-M) normed composite score | screening, wk -1, baseline, wk 1,3,6 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| CNS-VS-M un-normed composite score | screening, wk-1,baseline,wk1,3,6 |
| Global Improvement in Cognition Clinician and Patient Versions (GIC-CV;GIC-PV) | wk 1,3,6 |
| Safety assessments, including adverse events, electrocardiographic assessments, neuropsychiatric assessments (performed weekly), physical exam, and laboratory measures | weekly |
| Severity Item for Cognitive Impairment-Clinician and Patient Versions (SICI-CV; SICI-PV) | baseline, wk6 |
Outcome results
None listed