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Phase II Study to Assess RG2417 in the Treatment of 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: NCT00322764
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : November 9, 2007
Information provided by:
Repligen Corporation

Tracking Information
First Submitted Date  ICMJE May 4, 2006
First Posted Date  ICMJE May 8, 2006
Last Update Posted Date November 9, 2007
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2006)
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
Official Title  ICMJE Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of RG2417 in the Treatment of Bipolar I Depression
Brief Summary The primary purpose of this study is to determine the safety and efficacy of oral RG2417 (Uridine) when administered to patients with Bipolar I depression twice daily for six weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Bipolar Depression
Intervention  ICMJE Drug: Uridine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 4, 2006)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. DSM-IV-TR diagnosis of Bipolar I Depression
  2. 18 to 65 years of age, inclusive
  3. Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
  4. Duration of current depressive episode of at least four weeks by Day 1
  5. Competent to give informed consent

Exclusion Criteria:

  1. Manic/hypomanic/mixed episode as determined by the MINI at Screening and/or a Young Mania Rating Scale (YMRS) score of > 12 at Screening and/or Day 1
  2. Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
  3. A history of alcohol or substance dependence within six months of Day 1, or a history of alcohol or substance abuse within three months of Day 1
  4. Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
  5. An Axis II diagnosis that is likely to interfere with protocol compliance
  6. Initiation of or increase in psychotherapy within 4 weeks of Screening
  7. Psychotropic medication (excluding fluoxetine) within 24 hours of initiation of study drug on Day 1; fluoxetine within 2 weeks of initiation of study drug on Day 1
  8. Serious suicidal or homicidal risk as determined by the investigator and/or a score of > 5 on the suicide item #10 of the MADRS at Screening and/or Day 1
  9. History of sensitivity to any of the ingredients in the study drug
  10. Clinically significant abnormality in any screening laboratory results
  11. Clinically significant organic disease, including cardiovascular, endocrine, hepatic, pulmonary, neurologic, or renal disease, or any other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures
  12. Women who are pregnant, breastfeeding, or refuse to use adequate birth control
  13. Current seizure disorder
  14. Participation in an investigational drug study within twenty-eight days of Day 1
  15. Current psychotic episode
  16. Clozaril use and/or electroconvulsive therapy within six months of Day 1
  17. Failure of three or more adequate trials of standard therapies for depression during the current episode
  18. Current episode of depression is longer than one year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00322764
Other Study ID Numbers  ICMJE RG2417-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Repligen Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Jacoby, MD, PhD Repligen Corporation
PRS Account Repligen Corporation
Verification Date November 2007

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