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
1 other identifier
interventional
80
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 4, 2006
CompletedFirst Posted
Study publicly available on registry
May 8, 2006
CompletedNovember 9, 2007
November 1, 2007
May 4, 2006
November 8, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV-TR diagnosis of Bipolar I Depression
- to 65 years of age, inclusive
- Depressive phase, as measured by MADRS greater than or equal to 20 at Screening and Day1
- Duration of current depressive episode of at least four weeks by Day 1
- Competent to give informed consent
You may not qualify if:
- 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
- Dementia or any current Axis I diagnosis (excluding bipolar I) requiring pharmacological treatments
- 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
- Urine drug screen positive for amphetamines, cocaine metabolites, opiates and/or phencyclindine (PCP)
- An Axis II diagnosis that is likely to interfere with protocol compliance
- Initiation of or increase in psychotherapy within 4 weeks of Screening
- 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
- 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
- History of sensitivity to any of the ingredients in the study drug
- Clinically significant abnormality in any screening laboratory results
- 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
- Women who are pregnant, breastfeeding, or refuse to use adequate birth control
- Current seizure disorder
- Participation in an investigational drug study within twenty-eight days of Day 1
- Current psychotic episode
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford University
Stanford, California, 94305, United States
Carman Research
Smyrna, Georgia, 30080, United States
Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, 46202, United States
Marc Hertzman, MD, PC
Rockville, Maryland, 20852, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Medical & Behavioral Health Research, PC
New York, New York, 10023, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Future Search Trials of Austin
Austin, Texas, 78756, United States
Future Search Trials of Dallas
Dallas, Texas, 75231, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Jacoby, MD, PhD
Repligen Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 4, 2006
First Posted
May 8, 2006
Study Start
March 1, 2006
Last Updated
November 9, 2007
Record last verified: 2007-11