Uridine in Bipolar I Depression Clinical Trial

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

The goal of this study is to measure the effectiveness and safety of an investigational drug in treating Bipolar I Depression.  A drug is deemed investigational when the U.S. Food and Drug Administration has not yet approved it to be sold, it can only be used for testing.

You will be in the study for up to 16 weeks: a screening period of up to 4 weeks, 8 weeks of study drug treatment with weekly visits and a 4 week follow-up visit.  There will be a total of 11 scheduled visits.  You may also be seen for other unscheduled visits at any time that the doctor thinks this is necessary.  You may also have up to 7 additional follow-up visits over a 3 month period after you stop taking the study drug, if your study doctor feels that this is needed to stabilize you on other medications while you are going back to your own physician’s care.

Potential participants will come to Johns Hopkins for a screening visit during which they will undergo several psychological and medical evaluations.  If you meet study criteria, the study doctor will slowly take you off medications that may affect your mind, mood or behavior.  After that time you will begin taking either the investigational drug or a placebo.  If you begin treatment in the study, you will meet with the study team every week to check for symptoms and potential side effects.  Participation includes free study medication, labs, and testing.  Participants will also be paid and after the study referred back to their treating psychiatrist with treatment recommendations.

A placebo is an inactive pill that looks like the study medication but is expected to have no effect.  Participants will have a 50% chance of getting the placebo.  Throughout the course of the study, neither participants nor researchers will know who is getting which treatment.

Please contact us for more information and an in-depth screening if you meet these basic criteria:

• Age 18-65
• Diagnosed with bipolar I disorder
• Currently depressed

 
For more information about this study call 410-502-2586 or email moodtrials@jhmi.edu