Riluzole in the Treatment of Bipolar Depression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bipolar Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Riluzole

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.

Group Type EXPERIMENTAL

Riluzole

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Rilutek

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No