Riluzole in the Treatment of Bipolar Depression
This study has been completed.
Sponsor:
Mclean Hospital
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00544544
First received: October 12, 2007
Last updated: March 9, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bipolar Depression |
Drug: Riluzole |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mclean Hospital:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 14 |
| Study Start Date: | June 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
|
Drug: Riluzole
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female age 18-65
- Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
- Current score of >/= 18 on the Hamilton Depression Scale
Exclusion Criteria:
- Active psychotic/manic symptoms
- Lifetime history of schizophrenia or obsessive compulsive disorder
- Clinically significant medical disease
- Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.
Contacts and Locations More Information
Publications:
| Responsible Party: | Brian P. Brennan, MD, Associate Director of Translational Neuroscience Research, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT00544544 History of Changes |
| Other Study ID Numbers: | 2007-P-000751 |
| Study First Received: | October 12, 2007 |
| Results First Received: | June 24, 2010 |
| Last Updated: | March 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mclean Hospital:
|
Bipolar depression |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Riluzole Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Neuroprotective Agents Protective Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on October 17, 2012
