Clinical trial NCT00099229: 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 and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 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: 2004-12-10
Enrollment: 320
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: This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.


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 3).
Secondary outcomes:
measure: Major improvement in anxiety and depression from baseline to endpoint (Week 3)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Port Charlotte
country: United States
facility: Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Investigational Site
state: Indiana
city: Newton
country: United States
facility: Investigational Site
state: Kansas
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Raleigh
country: United States
facility: Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Investigational Site
state: Texas
city: Bellaire
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Kirkland
country: United States
facility: Investigational Site
state: Washington
city: Dijon
country: France
facility: Investigational Site
city: Strasbourg
country: France
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: