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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00107939
First Posted: April 12, 2005
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
April 11, 2005
April 12, 2005
March 22, 2017
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)
Not Provided
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.
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Bipolar Disorder
Drug: Licarbazepine
Not Provided
Not Provided

*   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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00107939
CLIC477D2302
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2017

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