Riluzole in the Treatment of Bipolar Depression

Mass General Brigham

Status: Completed

Conditions: Bipolar Depression

Treatments: Drug: Riluzole

Study type: Interventional

Funder types: Other

Identifiers

NCT00544544

2007-P-000751

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Riluzole

Experimental group

Description:

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.

Treatment:

Drug: Riluzole