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

Purpose

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.

Condition	Intervention	Phase
Bipolar I Depression	Drug: RG2417 Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

U.S. FDA Resources

Further study details as provided by Repligen Corporation:

Primary Outcome Measures:

MADRS Score [ Time Frame: Baseline and weekly for 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CGI-BP-S [ Time Frame: Baseline and weekly for 8 weeks ] [ Designated as safety issue: No ]
Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score) [ Time Frame: Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	November 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RG2417 Oral RG2417 taken twice daily for 8 weeks	Drug: RG2417 1g bid dose escalates to 2g bid for weeks 2-8. Other Name: Uridine
Placebo Comparator: Placebo Oral placebo taken twice daily for 8 weeks	Drug: Placebo Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets. Other Name: Sugar Pill

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812058

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Locations

United States, Alabama
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States, 35226
United States, Arkansas
K&S Professional Research Services
Little Rock, Arkansas, United States, 72201
United States, California
Affiliated Research Institute
San Diego, California, United States, 92108
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Florida
Behavioral Clinical Research
North Miami, Florida, United States, 33161
Clinical Neuroscience Solution, Inc.
Orlando, Florida, United States, 32806
University of South Florida College of Medicine
Tampa, Florida, United States, 33613
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
Carman Research
Smyrna, Georgia, United States, 30080
United States, Indiana
Valle Vista Health System
Greenwood, Indiana, United States, 46143
United States, Louisiana
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic Department of Pscyhiatry & Psychology
Rochester, Minnesota, United States, 55905
United States, New York
Behavioral Medical Research of States Island
Staten Island, New York, United States, 10305
United States, North Carolina
Unvieristy of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Richard H. Weisler, MD, PA and Associates
Raleigh, North Carolina, United States, 27609
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Western Psychiatric Institute Clinic
Pittsburg, Pennsylvania, United States, 15213
United States, Rhode Island
Lincoln Research
Lincoln, Rhode Island, United States, 02856
United States, South Carolina
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States, 29401
United States, Tennessee
CNS Healthcare
Memphis, Tennessee, United States, 38119
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37212
United States, Texas
FutureSearch Trials of Austin
Austin, Texas, United States, 78756
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75231
University of Texas, Houston Medical Center
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98004
United States, Wisconsin
Dean Foundation
Middleton, Wisconsin, United States, 53562

Sponsors and Collaborators

Repligen Corporation

Investigators

Principal Investigator:

Gary Sachs, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Hedy Dion, Repligen Corporation
ClinicalTrials.gov Identifier:	NCT00812058 History of Changes
Other Study ID Numbers:	RG2417-03
Study First Received:	December 18, 2008
Last Updated:	January 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Repligen Corporation:

Bipolar Depression
Bipolar Disease
Bipolar Disorder

Bipolar
Manic Depression
Manic Depressive Disorder

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013