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

This study has been completed.
Sponsor:
Information provided by:
Repligen Corporation
ClinicalTrials.gov Identifier:
NCT00812058
First received: December 18, 2008
Last updated: January 13, 2011
Last verified: January 2011

December 18, 2008
January 13, 2011
November 2008
December 2010   (final data collection date for primary outcome measure)
MADRS Score [ Time Frame: Baseline and weekly for 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812058 on ClinicalTrials.gov Archive Site
  • CGI-BP-S [ Time Frame: Baseline and weekly for 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Bipolar I Depression
  • Drug: RG2417
    1g bid dose escalates to 2g bid for weeks 2-8.
    Other Name: Uridine
  • Drug: Placebo
    Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.
    Other Name: Sugar Pill
  • Experimental: RG2417
    Oral RG2417 taken twice daily for 8 weeks
    Intervention: Drug: RG2417
  • Placebo Comparator: Placebo
    Oral placebo taken twice daily for 8 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00812058
RG2417-03
Yes
Hedy Dion, Repligen Corporation
Repligen Corporation
Not Provided
Principal Investigator: Gary Sachs, MD Massachusetts General Hospital
Repligen Corporation
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP