Riluzole in the Treatment of Bipolar Depression

This study has been completed.
Sponsor:
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
  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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 April 20, 2014