A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
NCT ID: NCT00812058
Last Updated: 2011-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2008-11-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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RG2417
Oral RG2417 taken twice daily for 8 weeks
RG2417
1g bid dose escalates to 2g bid for weeks 2-8.
Placebo
Oral placebo taken twice daily for 8 weeks
Placebo
Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Repligen Corporation
INDUSTRY
Responsible Party
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Repligen Corporation
Principal Investigators
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Gary Sachs, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States
CNS Healthcare
Memphis, Tennessee, United States
Vanderbilt University School of Medicine
Nashville, Tennessee, United States
FutureSearch Trials of Austin
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
University of Texas, Houston Medical Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Dean Foundation
Middleton, Wisconsin, United States
Countries
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Other Identifiers
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RG2417-03
Identifier Type: -
Identifier Source: org_study_id
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