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

NCT01674010 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2019-10-21

Study results available
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Summary

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.

Conditions

  • Bipolar 1 Disorder

Interventions

DRUG

ELND005

DRUG

Lamotrigine

DRUG

Valproic acid

DRUG

Placebo

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY

  • OPKO Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Poland
  • Romania
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674010 on ClinicalTrials.gov