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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

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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: Uridine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of RG2417 in the Treatment of Bipolar I Depression
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo

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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

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): NCT00322764

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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Georgia
Carman Research
Smyrna, Georgia, United States, 30080
United States, Indiana
Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, United States, 46202
United States, Maryland
Marc Hertzman, MD, PC
Rockville, Maryland, United States, 20852
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Medical & Behavioral Health Research, PC
New York City, New York, United States, 10023
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Texas
Future Search Trials of Austin
Austin, Texas, United States, 78756
Future Search Trials of Dallas
Dallas, Texas, United States, 75231
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repligen Corporation
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Study Director: David Jacoby, MD, PhD Repligen Corporation
Layout table for additonal information Identifier: NCT00322764    
Other Study ID Numbers: RG2417-01
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: November 9, 2007
Last Verified: November 2007
Keywords provided by Repligen Corporation:
manic depression
bipolar disorder
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders