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Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
Trial ID: NCT01674010
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.
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
- 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.
- Woman of childbearing potential who is unwilling or unable to use an acceptable method
of birth control or is using a prohibited contraceptive method.
- 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
- 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.
drug: Valproic acid
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