Clinical Trials Logo
  1. Home
  2. Bipolar Disorder
  3. NCT00107926
  4. Details
NCT00107926 Clinical Trial

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

Bipolar Disorder Clinical Trial

Official title:
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00107926
Other study ID # CLIC477D2303
Secondary ID
Status Completed
Phase Phase 3
First received April 11, 2005
Last updated March 20, 2017
Start date October 2004
Est. completion date August 2007

Study information
Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 343
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Licarbazepine

• Placebo

Locations
Country Name City State
Austria Novartis Investigational Site Vienna
Canada Novartis Investigational Site Kelowna
Canada Novartis investigator site London
Canada Novartis investigator site Montreal
Canada Novartis investigator site Sudbury
Canada Novartis investigator site Vancouver
Canada Novartis investigator site Verdun
Colombia Guatemala Bogota
Colombia Guatemala Medellin
Colombia Guatemala Pareira
Czech Republic Novartis Investigational Site Brno
Czech Republic Novartis Investigational Site Hradec Kralove
Czech Republic Novartis Investigational Site Prague
Germany Novartis Investigational Site Berlin
Germany Novartis Investigational Site Bochum
Germany Novartis Investigational Site Dresden
Germany Novartis Investigational Site Ingolstadt
Germany Novartis Investigational Site Mannheim
Germany Novartis Investigational Site Wurzburg
Guatemala Novartis Investigational Site Guatemala city
Peru Novartis Investigational Site Lima
Russian Federation Novartis Investigational Site Moscow
Russian Federation Novartis Investigational Site Yaroslavl
Slovakia Novartis Investigational Site Bojnice
Slovakia Novartis Investigational Site Michalovce
South Africa Novartis Investigational Site Durban
Ukraine Novartis Investigational Site Dnepropetrovsk
Ukraine Novartis Investigational Site Kiev
Ukraine Novartis Investigational Site Lugansk
Ukraine Novartis Investigational Site Odessa
Ukraine Novartis Investigational Site Simferopol
United States Investigational Site Bellaire Texas
United States Investigational Site Bellevue Washington
United States Investigational Site Dallas Texas
United States Investigational Site Farmington Hills Michigan
United States Investigational Site Kansas City Kansas
United States Investigational Site Kirkland Washington
United States Investigational Site La Palma California
United States Investigational Site Madison Tennessee
United States Investigational Site Shreveport Louisiana
United States Investigational Site Somerville Massachusetts
United States Investigational Site Staten Island New York
United States Investigational Site West Allis Wisconsin
Venezuela Novartis Investigational Site Caracas

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Venezuela,  Austria,  Canada,  Colombia,  Czech Republic,  Germany,  Guatemala,  Peru,  Russian Federation,  Slovakia,  South Africa,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).
Secondary Major improvement in anxiety and depression from baseline to endpoint (week 6)
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2

External Links