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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00107939
First received: April 11, 2005
Last updated: November 22, 2011
Last verified: November 2011
History of Changes

April 11, 2005
November 22, 2011
November 2004
April 2007   (final data collection date for primary outcome measure)
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)
Reduction of the mean total score of the Young Mania Rating Scale (YMRS) from baseline to endpoint (week 6)
Complete list of historical versions of study NCT00107939 on ClinicalTrials.gov Archive Site
Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.
Same as current
 
 
 
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Licarbazepine 750 ¿ 2000 mg/d as Adjunctive Therapy to an Atypical Antipsychotic in the Treatment of Manic Episodes of Bipolar I Disorder Over 6 Weeks

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.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Bipolar Disorder
Drug: Licarbazepine
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
453
April 2007
April 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
 
NCT00107939
CLIC477D2302
 
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
 
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