Riluzole in the Treatment of Bipolar Depression

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544544
• Other study ID #: 2007-P-000751
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2018
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brennan BP, Hudson JI, Jensen JE, McCarthy J, Roberts JL, Prescot AP, Cohen BM, Pope HG Jr, Renshaw PF, Ongür D. Rapid enhancement of glutamatergic neurotransmission in bipolar depression following treatment with riluzole. Neuropsychopharmacology. 2010 Fe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale	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.	Baseline (week 0) - week 6
Secondary	Montgomery Asberg Depression Rating Scale	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.	Baseline (week 0) - week 6
Secondary	Young Mania Rating Scale	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.	Baseline (week 0) - week 6
Secondary	Clinical Global Impression Scale	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).	Baseline (week 0) - week 6