Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00107926
First received: April 11, 2005
Last updated: November 16, 2011
Last verified: November 2011
History of Changes

April 11, 2005
November 16, 2011
October 2004
August 2007   (final data collection date for primary outcome measure)
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).
Not Provided
Complete list of historical versions of study NCT00107926 on ClinicalTrials.gov Archive Site
Major improvement in anxiety and depression from baseline to endpoint (week 6)
Not Provided
Not Provided
Not Provided
 
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Licarbazepine
  • Drug: Placebo
  • Experimental: licarbazepine
    Intervention: Drug: Licarbazepine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
343
August 2007
August 2007   (final data collection date for primary outcome measure)

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:

  • 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Colombia,   Czech Republic,   Germany,   Guatemala,   Peru,   Russian Federation,   Slovakia,   South Africa,   Ukraine,   Venezuela
 
NCT00107926
CLIC477D2303
Not Provided
Not Provided
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP