A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Bipolar I Depression

In brief

The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.

Key facts

Study ID

NCT00812058

Run by

Repligen Corporation

People needed

180

Starts

2008-11-01

Expected to finish

2010-12-01

Last updated by the study team

2011-01-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bipolar I Disorder, most recent episode depressed
• History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms

You may not qualify if…

• Current manic, hypomanic or mixed episode
• Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
• Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
• Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
• Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
• Axis II diagnosis likely to interfere with study compliance
• Serious suicidal or homicidal risk
• Sensitivity to any of the drug ingredients, including lactose
• Women who are pregnant, breast feeding or refuse to use adequate birth control
• Current seizure disorder
• Current episode of depression is longer than 1 year

Where it is running

• Birmingham Psychiatry Pharmaceutical Studies, Inc. — Birmingham, Alabama, United States
• K&S Professional Research Services — Little Rock, Arkansas, United States
• Affiliated Research Institute — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• Behavioral Clinical Research — North Miami, Florida, United States
• Clinical Neuroscience Solution, Inc. — Orlando, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Carman Research — Smyrna, Georgia, United States
• Valle Vista Health System — Greenwood, Indiana, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mayo Clinic Department of Pscyhiatry & Psychology — Rochester, Minnesota, United States
• Behavioral Medical Research of States Island — Staten Island, New York, United States
• Unvieristy of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Richard H. Weisler, MD, PA and Associates — Raleigh, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• IPS Research Company — Oklahoma City, Oklahoma, United States
• Oregon Center for Clinical Investigations, Inc. — Portland, Oregon, United States
• Western Psychiatric Institute Clinic — Pittsburgh, Pennsylvania, United States
• Lincoln Research — Lincoln, Rhode Island, United States

Full record on ClinicalTrials.gov

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