A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
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
1 other identifier
interventional
180
1 country
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJanuary 17, 2011
January 1, 2011
2.1 years
December 18, 2008
January 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MADRS Score
Baseline and weekly for 8 weeks
Secondary Outcomes (2)
CGI-BP-S
Baseline and weekly for 8 weeks
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
Study Arms (2)
RG2417
EXPERIMENTALOral RG2417 taken twice daily for 8 weeks
Placebo
PLACEBO COMPARATOROral placebo taken twice daily for 8 weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
K&S Professional Research Services
Little Rock, Arkansas, 72201, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Yale University
New Haven, Connecticut, 06519, United States
Behavioral Clinical Research
North Miami, Florida, 33161, United States
Clinical Neuroscience Solution, Inc.
Orlando, Florida, 32806, United States
University of South Florida College of Medicine
Tampa, Florida, 33613, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Carman Research
Smyrna, Georgia, 30080, United States
Valle Vista Health System
Greenwood, Indiana, 46143, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Mayo Clinic Department of Pscyhiatry & Psychology
Rochester, Minnesota, 55905, United States
Behavioral Medical Research of States Island
Staten Island, New York, 10305, United States
Unvieristy of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Richard H. Weisler, MD, PA and Associates
Raleigh, North Carolina, 27609, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210, United States
Western Psychiatric Institute Clinic
Pittsburgh, Pennsylvania, 15213, United States
Lincoln Research
Lincoln, Rhode Island, 02856, United States
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401, United States
CNS Healthcare
Memphis, Tennessee, 38119, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, 37212, United States
FutureSearch Trials of Austin
Austin, Texas, 78756, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75231, United States
University of Texas, Houston Medical Center
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Dean Foundation
Middleton, Wisconsin, 53562, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Sachs, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 19, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
January 17, 2011
Record last verified: 2011-01