N/A
Completed N=14
Riluzole in the Treatment of Bipolar Depression
Source: ClinicalTrials.gov NCT00544544 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcomePrimary: Change in Hamilton Depression Rating Scale — -12.6 units on a scale — p=<.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Depression Rating Scale |
-12.6 | <.001 sig |
| SECONDARY Montgomery Asberg Depression Rating Scale |
-13.0 | <0.001 sig |
| SECONDARY Young Mania Rating Scale |
-0.6 | 0.38 |
| SECONDARY Clinical Global Impression Scale |
-1.6 | <0.001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00544544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.