Schizophrenia Clinical Trial
Official title:
A Randomized Double-Blind Placebo-Controlled 12-Week Phase 2 Study of Two Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist(EVP-6124)or Placebo in Schizophrenia Subjects on Chronic Stable Atypical Anti-Psychotic Therapy
This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.
This is a randomized, double-blind, placebo-controlled, Phase 2 safety/efficacy study in
which two dose levels of EVP-6124 will be evaluated. Eligible for enrollment will be patients
who meet clinical criteria for schizophrenia and who are taking chronic atypical
anti-psychotic medication at a stable dose. This study will therefore evaluate the effects of
EVP-6124 when administered concomitantly with anti-psychotic medication.
Patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg EVP-6124, or
placebo. Seventy-five patients per group. Study drug will be supplied as capsules and will be
orally administered once daily for a total of 84 days.
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