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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00099229

Collaborator

(none)

320

Enrollment

Locations

Duration (Months)

14.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: Licarbazepine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3). []

Secondary Outcome Measures

Major improvement in anxiety and depression from baseline to endpoint (Week 3) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Little Rock	Arkansas	United States	72211
2	Investigational Site	Cerritos	California	United States	90703
3	Investigational Site	San Diego	California	United States	92126
4	Investigational Site	Port Charlotte	Florida	United States	33952
5	Investigational Site	Indianapolis	Indiana	United States	46222
6	Investigational Site	Newton	Kansas	United States	67114
7	Investigational Site	Las Vegas	Nevada	United States	89103
8	Investigational Site	Raleigh	North Carolina	United States	27609
9	Investigational Site	Cincinnati	Ohio	United States	45267
10	Investigational Site	Oklahoma City	Oklahoma	United States	73118
11	Investigational Site	Philadelphia	Pennsylvania	United States	19124
12	Investigational Site	Austin	Texas	United States	78756
13	Investigational Site	Bellaire	Texas	United States	77401
14	Investigational Site	Houston	Texas	United States	77007
15	Investigational Site	Houston	Texas	United States	77021
16	Investigational Site	Kirkland	Washington	United States	98033
17	Investigational Site	Dijon		France	21033
18	Investigational Site	Strasbourg		France	67091
19	Investigational Site	Moscow		Russian Federation	107076
20	Investigational Site	Moscow		Russian Federation	113152
21	Investigational Site	Moscow		Russian Federation	123367
22	Investigational Site	St. Petersburg		Russian Federation	193019