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

January 13, 2011 updated by: Repligen Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MADRS Score
Time Frame: Baseline and weekly for 8 weeks
Baseline and weekly for 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CGI-BP-S
Time Frame: Baseline and weekly for 8 weeks
Baseline and weekly for 8 weeks
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
Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repligen Corporation

Investigators

  • Principal Investigator: Gary Sachs, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 17, 2011

Last Update Submitted That Met QC Criteria

January 13, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG2417-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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