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

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322764
• Other study ID #: RG2417-01
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2006
• Last updated: November 8, 2007
• Start date: March 2006

Study information

• Verified date: November 2007
• Source: Repligen Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Uridine

Locations

Country	Name	City	State
United States	Future Search Trials of Austin	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Future Search Trials of Dallas	Dallas	Texas
United States	Indiana University-Purdue University Indianapolis	Indianapolis	Indiana
United States	Medical & Behavioral Health Research, PC	New York City	New York
United States	Marc Hertzman, MD, PC	Rockville	Maryland
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Carman Research	Smyrna	Georgia
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Repligen Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo