Clinical trial NCT00107939: Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: bipolar disorder
manic episode
treatment
licarbazepine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-04-12
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6)
Secondary outcomes:
measure: Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Orange
country: United States
facility: Investigational Site
state: California
city: Pico Rivera
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Boca Raton
country: United States
facility: Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Joliet
country: United States
facility: Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Investigational Site
state: Indiana
city: Topeka
country: United States
facility: Investigational Site
state: Kansas
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site
state: Missouri
city: Brooklyne
country: United States
facility: Invetigational Site
state: New York
city: Cedarhurst
country: United States
facility: Investigational Site
state: New York
city: New York
country: United States
facility: Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Providence
country: United States
facility: Investigational Site
state: Rhode Island
city: Bellaire
country: United States
facility: Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Investigational Site
state: Washington
city: West Allis
country: United States
facility: Investigational Site
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: