Riluzole in the Treatment of Bipolar Depression
Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Riluzole in the Treatment of Bipolar Depression: A Study of the Association Between Clinical Response and Change in Brain Glutamate Levels as Measured by Proton Magnetic Resonance Spectroscopy|
- Change in Hamilton Depression Rating Scale [ Time Frame: Change from baseline to week 6 ] [ Designated as safety issue: No ]The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. The best score is zero (reflecting no depression) and the worst score is 63 (reflecting severe depression).
- Montgomery Asberg Depression Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Young Mania Rating Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Riluzole 50 mg twice daily for 2 weeks, increased to riluzole 50 mg in the morning and 100 mg in the evening for 1 week if tolerated, with a further increase to riluzole 100 mg twice daily if tolerated for 3 weeks.
50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks
Other Name: Rilutek
We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544544
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Dost Ongur, M.D, Ph.D.||Mclean Hospital|