A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder
The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : ELND005
- drug : Placebo
- drug : Valproic acid
- drug : Lamotrigine
Phase: Phase 2
Ages Eligible For Study:
- Meets the DSM-IV-TR criteria for BPD I by the SCID, prior to the Screening Visit. - Has a history in the last 3 years of ? 1 manic or mixed episodes of sufficient severity that required hospitalization and/or treatment with a mood stabilizer or antipsychotic, or confirmed by a family member or medical records to ensure the episode fulfills the DSM-IV-TR criteria. - Has experienced a mood episode of any polarity within 4 months prior to the Screening Visit and responded to StOC therapy. - Is euthymic at the Screening Visit (ie, score of ? 12 on the MADRS and a score of ? 12 on the Y-MRS). - Is receiving maintenance treatment for his or her BPD I with either LTG or VPA; on stable doses for past 4 weeks and therapeutic drug levels (total VPA 50--125 µg/mL and LTG 10-50 µmol/L or as deemed appropriate by the investigator). Dose adjustments made for tolerability reasons will be acceptable. A study patient must meet the following additional criteria to be eligible for randomization in the Double-blind Randomization Phase of this study: - Maintained in a stable euthymic state during Phase 1, defined as Y-MRS and MADRS scores of ? 12, with the following exceptions: a maximum of 2 nonconsecutive excursions will be allowed throughout Phase 1. Excursions are defined as Y-MRS or MADRS scores >12 but ? 16.