Working... Menu

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

Layout table for study information
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

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

  Show 36 Study Locations
Sponsors and Collaborators
Repligen Corporation
Layout table for investigator information
Principal Investigator: Gary Sachs, MD Massachusetts General Hospital

Layout table for additonal information
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:
Layout table for MeSH terms
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders