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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00107939

Collaborator

(none)

453

Enrollment

Locations

28.9

Duration (Months)

20.6

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

453 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, 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

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6) []

Secondary Outcome Measures

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

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	72201
2	Investigational Site	Orange	California	United States	92868
3	Investigational Site	Pico Rivera	California	United States	90660
4	Investigational Site	San Diego	California	United States	92108
5	Investigational Site	San Diego	California	United States	92126
6	Investigational Site	Boca Raton	Florida	United States	33432
7	Investigational Site	Atlanta	Georgia	United States	30308
8	Investigational Site	Chicago	Illinois	United States	60640
9	Investigational Site	Joliet	Illinois	United States	60435
10	Investigational Site	Indianapolis	Indiana	United States	46222
11	Investigational Site	Topeka	Kansas	United States	66606
12	Investigational Site	Kansas City	Missouri	United States	64133
13	Investigational Site	St. Louis	Missouri	United States	63104
14	Invetigational Site	Brooklyne	New York	United States	11201
15	Investigational Site	Cedarhurst	New York	United States	11516
16	Investigational Site	New York	New York	United States	10003
17	Investigational Site	Cincinnati	Ohio	United States	45267
18	Investigational Site	Columbus	Ohio	United States	43210
19	Investigational Site	Providence	Rhode Island	United States	02903
20	Investigational Site	Bellaire	Texas	United States	77401
21	Investigational Site	Bellevue	Washington	United States	98004
22	Investigational Site	West Allis	Wisconsin	United States	53227