Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
- Conditions
- Bipolar I Disorder.Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-001935-30-ES
- Lead Sponsor
- Elan Pharma International Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
-Woman of childbearing potential who is unwilling or unable to use an acceptable method of birth control or is using a prohibited contraceptive method.
-Has a history of rapid cycling BPD I with >= 8 cycles within the last year.
-Is found to be actively suicidal on the C-SSRS (answer of yes to question 4 or 5 [current or over the last 30 days]) or a score of >= 4 on the MADRS item 10 at the Screening Visit.
-Has suboptimally treated thyroid disease as evidenced by thyroid-stimulating hormone (TSH) >3 mIU/L at the Screening Visit.
-Has received electroconvulsive therapy (ECT) during the current episode or within 6 months prior to the Screening Visit.
-Has an estimated glomerular filtration rate <40 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula.
A study patient who meets ANY of the above and ANY of the criteria below will not be eligible for enrollment in the Double-blind Randomization Phase of this study:
-Has current signs or symptoms of psychosis.
-Has become actively suicidal as defined by C-SSRS answer of yes to question 4 or 5 (current or over the last 30 days) and/or has a score of >= 4 on MADRS item 10
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of ELND005 compared to placebo as adjunctive maintenance therapy in patients with BPD I.<br><br>To assess the safety and tolerability of ELND005 in BPD I patients.;Secondary Objective: To assess additional efficacy, pharmacokinetic (PK), and pharmacodynamic (PD) endpoints.;Primary end point(s): Time to recurrence of any mood episode (depressive, manic/hypomanic, or mixed episode), whichever occurs first, during the randomized phase of the study.;Timepoint(s) of evaluation of this end point: 48 weeks
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: up to 48 weeks;Secondary end point(s): -Proportion of study patients with recurrence of any mood episode<br>-Time to recurrence of a depressive episode<br>-Time to recurrence of a manic/hypomanic or a mixed episode <br>-Proportion of study patients with recurrence of a depressive episode<br>-Proportion of study patients with recurrence of a manic/hypomanic or a mixed episode<br>-Mean change from baseline to endpoint in HAM-A<br>-Mean change from baseline to endpoint in CGI-BP-S for mania, depression, and overall bipolar illness