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

Completed · Phase 2

Conditions studied: Bipolar Depression

In brief

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.

Key facts

Study ID

NCT00322764

Run by

Repligen Corporation

People needed

80

Starts

2006-03-01

Last updated by the study team

2007-11-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-IV-TR diagnosis of Bipolar I Depression
• 18 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
• Clozaril use and/or electroconvulsive therapy within six months of Day 1
• Failure of three or more adequate trials of standard therapies for depression during the current episode
• Current episode of depression is longer than one year

Where it is running

• 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

Full record on ClinicalTrials.gov

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