An interventional study of Riluzole in Bipolar Depression, sponsored by Mclean Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by Mclean Hospital · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 14 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Mclean Hospital is the lead sponsor of 181 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: Rilutek
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.
Time frame: Baseline (week 0) - week 6
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.
Time frame: Baseline (week 0) - week 6
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.
Time frame: Baseline (week 0) - week 6
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).
Time frame: Baseline (week 0) - week 6
| Milestone | Riluzole |
|---|---|
| Started | 14 |
| Completed | 11 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| units on a scale | Riluzole |
|---|---|
| Change in Hamilton Depression Rating Scale | -12.6 (-16.5 to -8.6) |
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.
| units on a scale | Riluzole |
|---|---|
| Montgomery Asberg Depression Rating Scale | -13.0 (-18.0 to -8.0) |
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.
| units on a scale | Riluzole |
|---|---|
| Young Mania Rating Scale | -0.6 (-2.0 to 0.7) |
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).
| units on a scale | Riluzole |
|---|---|
| Clinical Global Impression Scale | -1.6 (-2.4 to -0.8) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Riluzole | — | 0/14 (0%) | 14/14 (100%) |
| Event | Riluzole |
|---|---|
| nauseaGastrointestinal disorders | 6/14 |
| headacheNervous system disorders | 4/14 |
| diarrheaGastrointestinal disorders | 4/14 |
| insomniaNervous system disorders | 4/14 |
| constipationGastrointestinal disorders | 3/14 |
| sedationNervous system disorders | 3/14 |
| neck painMusculoskeletal and connective tissue disorders | 3/14 |
| dyspneaRespiratory, thoracic and mediastinal disorders | 2/14 |
| dizzinessNervous system disorders | 2/14 |
| dry mouthGeneral disorders | 2/14 |
| Age, Categorical(Participants) | Riluzole |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Age, Continuous(years) | Riluzole |
|---|---|
| Mean | 44.5 ± 12.0 |
| Sex: Female, Male(Participants) | Riluzole |
|---|---|
| Female | 7 |
| Male | 7 |
| Region of Enrollment(participants) | Riluzole |
|---|---|
| United States | 14 |
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Mclean Hospital