Overview

Safety and Cognitive Function Study of EVP-6124 in Patients With Schizophrenia

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
FORUM Pharmaceuticals Inc
Collaborators:
INC Research
Syneos Health
Treatments:
Nicotinic Agonists
Criteria
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