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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: Uridine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Uridine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of MADRS and CGI BP C for RG2417 treatment in comparison to placebo |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manic depression, bipolar disorder, depression, uridine, RG2417