Phase II Study to Assess RG2417 in the Treatment of Bipolar I Depression
NCT ID: NCT00322764
Last Updated: 2007-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2006-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Uridine
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Repligen Corporation
INDUSTRY
Principal Investigators
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David Jacoby, MD, PhD
Role: STUDY_DIRECTOR
Repligen Corporation
Locations
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Stanford University
Stanford, California, United States
Carman Research
Smyrna, Georgia, United States
Indiana University-Purdue University Indianapolis
Indianapolis, Indiana, United States
Marc Hertzman, MD, PC
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Medical & Behavioral Health Research, PC
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Future Search Trials of Austin
Austin, Texas, United States
Future Search Trials of Dallas
Dallas, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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RG2417-01
Identifier Type: -
Identifier Source: org_study_id