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, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107939
• Other study ID #: CLIC477D2302
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2005
• Last updated: March 20, 2017
• Start date: November 2004
• Est. completion date: April 2007

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: April 2007
• Est. primary completion date: April 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Drug:
• Licarbazepine

Locations

Country	Name	City	State
United States	Investigational Site	Atlanta	Georgia
United States	Investigational Site	Bellaire	Texas
United States	Investigational Site	Bellevue	Washington
United States	Investigational Site	Boca Raton	Florida
United States	Invetigational Site	Brooklyne	New York
United States	Investigational Site	Cedarhurst	New York
United States	Investigational Site	Chicago	Illinois
United States	Investigational Site	Cincinnati	Ohio
United States	Investigational Site	Columbus	Ohio
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational Site	Joliet	Illinois
United States	Investigational Site	Kansas City	Missouri
United States	Investigational Site	Little Rock	Arkansas
United States	Investigational Site	New York	New York
United States	Investigational Site	Orange	California
United States	Investigational Site	Pico Rivera	California
United States	Investigational Site	Providence	Rhode Island
United States	Investigational Site	San Diego	California
United States	Investigational Site	San Diego	California
United States	Investigational Site	St. Louis	Missouri
United States	Investigational Site	Topeka	Kansas
United States	Investigational Site	West Allis	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

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	Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.

External Links

•   Results for CLIC477D2302 from Novartis Clinical Trials website