Riluzole in the Treatment of Bipolar Depression
|ClinicalTrials.gov Identifier: NCT00544544|
Recruitment Status : Completed
First Posted : October 16, 2007
Results First Posted : August 18, 2010
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: Riluzole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||July 2009|
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
- Change in Hamilton Depression Rating Scale [ Time Frame: Baseline (week 0) - week 6 ]The Hamilton Depression rating Scale is a clinician-rated scale that measures the severity of depression symptoms using 21 items. Minimum score is zero and maximum score is 65. Higher scores indicate more severe depressive symptoms.
- Montgomery Asberg Depression Rating Scale [ Time Frame: Baseline (week 0) - week 6 ]The Montgomery-Asberg Depression Rating Scale is a clinician-rated scale that measures the severity of depression symptoms. The 10 items measured are apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Minimum score is zero and maximum score is 60. Higher scores represent more severe depressive symptoms.
- Young Mania Rating Scale [ Time Frame: Baseline (week 0) - week 6 ]The Young Mania Rating Scale is a clinician-rated scale that measures the severity of mania symptoms. The 11 items measures are elevated mood, increased motor activity, sexual interest, sleep, irritability, speech, language-thought disorder, thought content, aggressive behavior, appearance, and insight. Minimum score is zero and maximum score is 60. Higher scores represent more severe mania symptoms.
- Clinical Global Impression Scale [ Time Frame: Baseline (week 0) - week 6 ]The Clinical Global Impression Scale is a clinician-rated scale that evaluates the severity of illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544544
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Dost Ongur, M.D, Ph.D.||Mclean Hospital|