Central Nervous System Diseases, Cognition, Schizophrenia
Conditions
Keywords
Schizophrenia, Central nervous System Diseases, Cognition
Brief summary
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.
Detailed description
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.
Interventions
DRUGEVP-6124
Arms: 1
DRUGPlacebo
Arm: 3
Sponsors
Syneos Health
FORUM Pharmaceuticals Inc
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
* Subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (SCI) * Must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks * Must have no more than moderate severity rating for negative symptoms: BPRS item ≤4 * A minimal level of extrapyramidal symptoms (EPS); Simpson-Angus Scale total score ≤6 * A minimal level of depression; Calgary Depression Scale total score ≤10 * Must have a general health status acceptable for participation in a 12-week clinical trial * Fluency (oral and written) in the language in which the standardized tests will be administered * If a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing
Exclusion criteria
General * Insufficiently controlled diabetes mellitus in the judgment of the investigator * Malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ * Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study * Unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of two doses of EVP-6124 (0.3, and 1.0 mg QD) versus placebo capsules (QD) for 84 days to subjects with schizophrenia who are on chronic stable atypical anti-psychotic therapy as determined by clinical safety and cognitive function. | 84 days |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Clinical Efficacy | 84 days |
Countries
Russia, Serbia, Ukraine, United States
Outcome results
None listed