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
  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:


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
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, see Learn About Clinical Studies.

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 August 27, 2014