Back to resultsRiluzole in the Treatment of Bipolar Depression
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Riluzole
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar, depression
Eligibility 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.
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Riluzole
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544544
Brief Title
Riluzole in the Treatment of Bipolar Depression
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Riluzole
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Riluzole
Other Intervention Name(s)
Rilutek
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Rating Scale
Description
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.
Time Frame
Baseline (week 0) - week 6
Secondary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale
Description
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.
Time Frame
Baseline (week 0) - week 6
Title
Young Mania Rating Scale
Description
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.
Time Frame
Baseline (week 0) - week 6
Title
Clinical Global Impression Scale
Description
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).
Time Frame
Baseline (week 0) - week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dost Ongur, M.D, Ph.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19956089
Citation
Brennan BP, Hudson JI, Jensen JE, McCarthy J, Roberts JL, Prescot AP, Cohen BM, Pope HG Jr, Renshaw PF, Ongur D. Rapid enhancement of glutamatergic neurotransmission in bipolar depression following treatment with riluzole. Neuropsychopharmacology. 2010 Feb;35(3):834-46. doi: 10.1038/npp.2009.191. Epub 2009 Dec 2.
Results Reference
result
Learn more about this trial
Riluzole in the Treatment of Bipolar Depression
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