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.

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.