A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.

Official Title
-----------------
A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression

Conditions
-----------------
Bipolar I Depression

Intervention / Treatment
-----------------
* Drug: RG2417
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar I Disorder, most recent episode depressed History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms Exclusion Criteria: Current manic, hypomanic or mixed episode Rapid cycling bipolar disorder (4 or more mood episodes in the last year) Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP) Axis II diagnosis likely to interfere with study compliance Serious suicidal or homicidal risk Sensitivity to any of the drug ingredients, including lactose Women who are pregnant, breast feeding or refuse to use adequate birth control Current seizure disorder Current episode of depression is longer than 1 year

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RG2417<br>Oral RG2417 taken twice daily for 8 weeks | Drug: RG2417<br>* 1g bid dose escalates to 2g bid for weeks 2-8.<br>* Other names: Uridine;|
| Placebo Comparator: Placebo<br>Oral placebo taken twice daily for 8 weeks | Drug: Placebo<br>* Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets.<br>* Other names: Sugar Pill;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS Score |  | Baseline and weekly for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-BP-S |  | Baseline and weekly for 8 weeks | 
| Safety Findings (includes AE frequency, YMRS Score and CSSR-S Score) |  | Baseline, 8 weeks of study drug dosing and one follow up visit at 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar, Bipolar Depression, Bipolar Disease, Bipolar Disorder, Manic Depression, Manic Depressive Disorder