Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

NCT00107926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2017-03-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.

Conditions

Interventions

DRUG

Licarbazepine

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States
  • Austria
  • Canada
  • Colombia
  • Czechia
  • Germany
  • Guatemala
  • Peru
  • Russia
  • Slovakia
  • South Africa
  • Ukraine
  • Venezuela

Study Locations

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Entities

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 NCT00107926 on ClinicalTrials.gov