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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00812058
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : January 17, 2011
Information provided by:
Repligen Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar I Depression Drug: RG2417 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. MADRS Score [ Time Frame: Baseline and weekly for 8 weeks ]

Secondary Outcome Measures :
  1. CGI-BP-S [ Time Frame: Baseline and weekly for 8 weeks ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00812058

  Hide Study 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
Principal Investigator: Gary Sachs, MD Massachusetts General Hospital

Responsible Party: Hedy Dion, Repligen Corporation Identifier: NCT00812058     History of Changes
Other Study ID Numbers: RG2417-03
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: January 17, 2011
Last Verified: January 2011

Keywords provided by Repligen Corporation:
Bipolar Depression
Bipolar Disease
Bipolar Disorder
Manic Depression
Manic Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders