Summary:
The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic therapy.
Inclusion Criteria:
- Age 18 to 50 years of age, inclusive
- Resides in a stable living situation, according to the investigator's judgment, and must have an identified informant who should be consistent throughout the study. Where possible, the informant should accompany the subject at a minimum to the screening, baseline (Day 1), and final study visits and be available for telephone interview throughout the study at all visits. The informant must interact with the subject at least 2 times a week
- Diagnosis of Schizophrenia of at least 3 years duration utilizing the SCID-I, direct clinical assessments, family, informants, and past medical records
- Treated with atypical antipsychotic drug (in any approved dosage form) other than Clozapine at a stable dose for at least 8 weeks prior to screening and be clinically stable; the subject must remain clinically stable (in the opinion of the principal investigator) through randomization
- Moderate Schizophrenia clinical symptom burden as defined by the following: no more than "moderate" rating for positive symptoms (hallucinations and delusions), with a Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item score ≤ 4, and no more than a "moderate" severity rating for formal thought disorder, with a Brief Psychiatric Rating Scale (BPRS) Conceptual Disorganization item score ≤ 4
- Simpson-Angus Scale (SAS) total score ≤ 6
- Calgary Depression Scale for Schizophrenia (CDSS) total score ≤ 10
- General health status acceptable for participation in a 26-week clinical study
- Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study
- Fluency (oral and written) in the language in which the standardized tests will be administered
- The ability to refrain from using any tobacco or other nicotine-containing products for at least 30 minutes before any cognitive testing
Qualified Participants May Receive:
Investigational medication and all study related visits a no cost. Possible compensation for each completed visit.