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Adjunctive Isradipine for the Treatment of Bipolar Depression
This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an "add-on" to lithium, valproate, and/or atypical antipsychotics for individuals currently experiencing a major depressive episode. Our hypothesis is that isradipine will be superior to placebo in improving depressive symptoms.
Details
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 2 |
| Start date | 2013-02 |
| Completion | 2014-04 |
Conditions
- Bipolar Disorder
Interventions
- Isradipine
- Placebo
Primary outcomes
- Change in MADRS (4 Weeks) — Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) in isradipine-treated epochs versus placebo-treated epochs. These scores represent total scores, and on the MADRS total scores range from 0-60. A higher score indicates increased depression severity.
Countries
United States