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

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Central Nervous System Diseases, Cognition

In brief

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.

Key facts

Study ID

NCT00968851

Run by

FORUM Pharmaceuticals Inc

People needed

317

Starts

2009-12-01

Expected to finish

2011-03-01

Last updated by the study team

2014-04-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Intergrated Medical and Behavioral Associates — Glendale, California, United States
• Excell Research — Oceanside, California, United States
• University of California, San Diego — San Diego, California, United States
• Affiliated Research Institute — San Diego, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Scientific Clinical Research, Inc. — North Miami, Florida, United States
• Uptown Research Institute — Chicago, Illinois, United States
• Alexian Brothers Behavioral Health — Hoffman Estates, Illinois, United States
• CBH Health, LLC — Rockville, Maryland, United States
• CRI Worldwide — Willingboro, New Jersey, United States
• Carolina Clinical Trials, Inc. — Charleston, South Carolina, United States
• Vanderbilt Psychiatric Hospital — Nashville, Tennessee, United States
• FutureSearch Clinical Trials, L.P. — Austin, Texas, United States
• InSite Clinical Research — DeSoto, Texas, United States
• Study site — Arkhangelsk, Russia
• Study site — Kazan', Russia
• Study site — Moscow, Russia
• Study site — Moscow, Russia
• Study site — Saint Petersburg, Russia
• Study site — Stavropol, Russia
• Clinical Site 1 — Belgrade, Serbia
• Clinical Site 2 — Belgrade, Serbia
• Clinical Site 3 — Belgrade, Serbia
• Study site — Kragujevac, Serbia
• Study site — Niš, Serbia

Full record on ClinicalTrials.gov

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