Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Bipolar 1 Disorder

In brief

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.

Key facts

Study ID

NCT01674010

Run by

OPKO Health, Inc.

People needed

309

Starts

2012-08-01

Expected to finish

2014-06-01

Last updated by the study team

2019-10-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 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.

Where it is running

• Elan Investigational Site — Glendale, Arizona, United States
• Elan Investigational Site — Phoenix, Arizona, United States
• Elan Investigational Site — Little Rock, Arkansas, United States
• Elan Investigational Site — Little Rock, Arkansas, United States
• Elan Investigational Site — Cerritos, California, United States
• Elan Investigational Site — Costa Mesa, California, United States
• Elan Investigational Site — Escondido, California, United States
• Elan Investigational Site — Garden Grove, California, United States
• Elan Investigational Site — National City, California, United States
• Elan Investigational Site — Oceanside, California, United States
• Elan Investigational Site — Palo Alto, California, United States
• Elan Investigational Site — Riverside, California, United States
• Elan Investigational Site — San Diego, California, United States
• Elan Investigational Site — Santa Ana, California, United States
• Elan Investigational Site — Stanford, California, United States
• Elan Investigational Site — Norwich, Connecticut, United States
• Elan Investigational Site — North Miami, Florida, United States
• Elan Investigational Site — Oakland Park, Florida, United States
• Elan Investigational Site — Tampa, Florida, United States
• Elan Investigational Site — Atlanta, Georgia, United States
• Elan Investigational Site — Roswell, Georgia, United States
• Elan Investigational Site — Creve Coeur, Missouri, United States
• Elan Investigational Site — St Louis, Missouri, United States
• Elan Investigational Site — St Louis, Missouri, United States
• Elan Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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