Clinical Trials Logo
  1. Home
  2. Bipolar Disorder
  3. NCT00099229
  4. Details
NCT00099229 Clinical Trial

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

Bipolar Disorder Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00099229
Other study ID # CLIC477D2301
Secondary ID
Status Completed
Phase Phase 3
First received December 10, 2004
Last updated February 21, 2017
Start date November 2004
Est. completion date August 2006

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

Clinical Trial Summary

This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

Recruitment information / eligibility
Status Completed
Enrollment 320
Est. completion date August 2006
Est. primary completion date August 2006
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

Locations
Country Name City State
France Investigational Site Dijon
France Investigational Site Strasbourg
Russian Federation Investigational Site Moscow
Russian Federation Investigational Site Moscow
Russian Federation Investigational Site Moscow
Russian Federation Investigational Site St. Petersburg
United States Investigational Site Austin Texas
United States Investigational Site Bellaire Texas
United States Investigational Site Cerritos California
United States Investigational Site Cincinnati Ohio
United States Investigational Site Houston Texas
United States Investigational Site Houston Texas
United States Investigational Site Indianapolis Indiana
United States Investigational Site Kirkland Washington
United States Investigational Site Las Vegas Nevada
United States Investigational Site Little Rock Arkansas
United States Investigational Site Newton Kansas
United States Investigational Site Oklahoma City Oklahoma
United States Investigational Site Philadelphia Pennsylvania
United States Investigational Site Port Charlotte Florida
United States Investigational Site Raleigh North Carolina
United States Investigational Site San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).
Secondary Major improvement in anxiety and depression from baseline to endpoint (Week 3)
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
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study

External Links