Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression

This study has been completed.
Sponsor:
Information provided by:
Repligen Corporation
ClinicalTrials.gov Identifier:
NCT00322764
First received: May 4, 2006
Last updated: November 8, 2007
Last verified: November 2007
  Purpose

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 Intervention Phase
Bipolar Depression
Drug: Uridine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by Repligen Corporation:

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

Estimated Enrollment: 80
Study Start Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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
  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: NCT00322764

Locations
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
Investigators
Study Director: David Jacoby, MD, PhD Repligen Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00322764     History of Changes
Other Study ID Numbers: RG2417-01
Study First Received: May 4, 2006
Last Updated: November 8, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Repligen Corporation:
manic depression
bipolar disorder
depression
uridine
RG2417

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

ClinicalTrials.gov processed this record on September 22, 2014