Conditions: Schizophrenia Schizoaffective Disorder Central Nervous System Diseases
Keywords: Schizophrenia Schizoaffective CNS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: no

Brief summary:
This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication.

Detailed description:
Study drug will be supplied as capsules and will be orally administered once daily for a total of 21 days. Eligible subjects will be admitted to an inpatient study unit on Day -6 (six days before the first dose of study drug is administered) and will remain confined to the inpatient study unit throughout the dosing phase. Safety assessments, PK sampling, and cognitive testing will be performed.

Arms:
arm 1: Matching placebo was administered as one capsule per day for 21 days. arm 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. arm 3: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.

Interventions: intervention 1: EVP-6124 (0.3 mg/day) intervention 2: EVP-6124 (1.0 mg/day) intervention 3: Placebo intervention 4: Antipsychotic therapy
Intervention descriptions: intervention 1: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days. intervention 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. intervention 3: Matching placebo was administered as one capsule per day for 21 days. intervention 4: Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.

Protocol document: