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Riluzole in the Treatment of Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00544544
Recruitment Status : Completed
First Posted : October 16, 2007
Results First Posted : August 18, 2010
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: Riluzole Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Riluzole

Arm Intervention/treatment
Experimental: 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.
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




Primary Outcome Measures :
  1. Change in Hamilton Depression Rating Scale [ Time Frame: Baseline (week 0) - week 6 ]
    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.


Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale [ Time Frame: Baseline (week 0) - week 6 ]
    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.

  2. Young Mania Rating Scale [ Time Frame: Baseline (week 0) - week 6 ]
    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.

  3. Clinical Global Impression Scale [ Time Frame: Baseline (week 0) - week 6 ]
    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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
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Principal Investigator: Dost Ongur, M.D, Ph.D. Mclean Hospital

Publications of Results:
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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 Posted: October 16, 2007    Key Record Dates
Results First Posted: August 18, 2010
Last Update Posted: August 7, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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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