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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
History of Changes
  Purpose

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 Intervention Phase
Bipolar I Depression
 Drug: RG2417
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Repligen Corporation:

Primary Outcome Measures:
  • MADRS Score [ Time Frame: Baseline and weekly for 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: November 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812058

  Show 36 Study Locations
Sponsors and Collaborators
Repligen Corporation
Investigators
Principal Investigator: Gary Sachs, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Hedy Dion, Repligen Corporation
ClinicalTrials.gov Identifier: NCT00812058     History of Changes
Other Study ID Numbers: RG2417-03
Study First Received: December 18, 2008
Last Updated: January 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Repligen Corporation:
Bipolar Depression
Bipolar Disease
Bipolar Disorder
 Bipolar
Manic Depression
Manic Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013