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Riluzole in the Treatment of Bipolar Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544544
First Posted: October 16, 2007
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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 Brian P. Brennan, MD, Mclean Hospital:

Primary Outcome Measures:
  • Change in Hamilton Depression Rating Scale [ Time Frame: Change from baseline to week 6 ]
    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 ]
  • Young Mania Rating Scale [ Time Frame: 6 weeks ]
  • Clinical Global Impression Scale [ Time Frame: 6 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544544


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Dost Ongur, M.D, Ph.D. Mclean Hospital
  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
First Submitted: October 12, 2007
First Posted: October 16, 2007
Results First Submitted: June 24, 2010
Results First Posted: August 18, 2010
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Brian P. Brennan, MD, Mclean Hospital:
Bipolar
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents