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

Dose-Escalating, Phase II Study to Assess the Safety and Tolerability of RG2417 in the Treatment of Bipolar I Depression

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Depression
• Intervention / Treatment: Drug: Uridine

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • Carman Research
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University-Purdue University Indianapolis
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Marc Hertzman, MD, PC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • New York City, New York, United States, 10023
      • Medical & Behavioral Health Research, PC
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Texas
    • Austin, Texas, United States, 78756
      • Future Search Trials of Austin
    • Dallas, Texas, United States, 75231
      • Future Search Trials of Dallas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo

Collaborators and Investigators

• Sponsor: Repligen Corporation
• Investigators: Study Director: David Jacoby, MD, PhD, Repligen Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2006

Study Registration Dates

• First Submitted: May 4, 2006
• First Submitted That Met QC Criteria: May 4, 2006
• First Posted (ESTIMATE): May 8, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): November 9, 2007
• Last Update Submitted That Met QC Criteria: November 8, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: depression; bipolar disorder; uridine; manic depression; RG2417
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder
• Other Study ID Numbers: RG2417-01