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

Bipolar I Depression Clinical Trial

Official title:

A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812058
• Other study ID #: RG2417-03
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2008
• Last updated: January 13, 2011
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Repligen Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar I Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• RG2417
1g bid dose escalates to 2g bid for weeks 2-8.
• Placebo
Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	FutureSearch Trials of Austin	Austin	Texas
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Birmingham Psychiatry Pharmaceutical Studies, Inc.	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Unvieristy of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Ralph H. Johnson VA Medical Center	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	FutureSearch Trials of Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Valle Vista Health System	Greenwood	Indiana
United States	University of Texas, Houston Medical Center	Houston	Texas
United States	Lincoln Research	Lincoln	Rhode Island
United States	K&S Professional Research Services	Little Rock	Arkansas
United States	CNS Healthcare	Memphis	Tennessee
United States	Dean Foundation	Middleton	Wisconsin
United States	Vanderbilt University School of Medicine	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Behavioral Clinical Research	North Miami	Florida
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solution, Inc.	Orlando	Florida
United States	Western Psychiatric Institute Clinic	Pittsburg	Pennsylvania
United States	Oregon Center for Clinical Investigations, Inc.	Portland	Oregon
United States	Richard H. Weisler, MD, PA and Associates	Raleigh	North Carolina
United States	Mayo Clinic Department of Pscyhiatry & Psychology	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Affiliated Research Institute	San Diego	California
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	Carman Research	Smyrna	Georgia
United States	Behavioral Medical Research of States Island	Staten Island	New York
United States	University of South Florida College of Medicine	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repligen Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS Score		Baseline and weekly for 8 weeks	No
Secondary	CGI-BP-S		Baseline and weekly for 8 weeks	No
Secondary	Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score)		Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks	Yes