CClinicalTrials.gg
CompletedNCT00107939Updated Mar 22, 2017

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

A Phase 3 interventional study of Licarbazepine in Bipolar Disorder, sponsored by Novartis Pharmaceuticals. Completed at 22 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
453
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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 therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.

02

Conditions studied

  • Bipolar Disorder

Keywords

  • bipolar disorder
  • manic episode
  • treatment
  • licarbazepine
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
  • In need of psychiatric treatment
  • Cooperation and willingness to complete all aspects of the study

Exclusion criteria

Exclusion Criteria:

  • Current diagnosis other than bipolar I disorder
  • History of schizophrenia or schizoaffective disorder
  • Drug dependence within 1 month prior to study start or testing positive in a urine drug test
  • Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
  • Any form of psychotherapy within 1 month prior to study start
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
453 participants (actual)

Interventions

  • DrugLicarbazepine
05

What researchers measure

Primary outcomes

  1. Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)

Secondary outcomes

  1. Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.

06

Study locations

22 sites
  • Investigational Site
    Little Rock, Arkansas 72201, United States
  • Investigational Site
    Orange, California 92868, United States
  • Investigational Site
    Pico Rivera, California 90660, United States
  • Investigational Site
    San Diego, California 92108, United States
  • Investigational Site
    San Diego, California 92126, United States
  • Investigational Site
    Boca Raton, Florida 33432, United States
  • Investigational Site
    Atlanta, Georgia 30308, United States
  • Investigational Site
    Chicago, Illinois 60640, United States
  • Investigational Site
    Joliet, Illinois 60435, United States
  • Investigational Site
    Indianapolis, Indiana 46222, United States
  • Investigational Site
    Topeka, Kansas 66606, United States
  • Investigational Site
    Kansas City, Missouri 64133, United States
  • Investigational Site
    St. Louis, Missouri 63104, United States
  • Invetigational Site
    Brooklyne, New York 11201, United States
  • Investigational Site
    Cedarhurst, New York 11516, United States
  • Investigational Site
    New York, New York 10003, United States
  • Investigational Site
    Cincinnati, Ohio 45267, United States
  • Investigational Site
    Columbus, Ohio 43210, United States
  • Investigational Site
    Providence, Rhode Island 02903, United States
  • Investigational Site
    Bellaire, Texas 77401, United States
  • Investigational Site
    Bellevue, Washington 98004, United States
  • Investigational Site
    West Allis, Wisconsin 53227, United States
07

Registry details

Key details

Study ID
NCT00107939
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 12, 2005
Start date
Nov 2004
Primary completion
Apr 2007
Completion
Apr 2007
Last update
Mar 22, 2017

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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