Clinical trial NCT00107926: Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Official title: Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
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: 343
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 treatment with either lithium or valproate, which 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: Major improvement in anxiety and depression from baseline to endpoint (week 6)
Other outcomes:
Locations:
city: La Palma
country: United States
facility: Investigational Site
state: California
city: Kansas City
country: United States
facility: Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: Investigational Site
state: Louisiana
city: Somerville
country: United States
facility: Investigational Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: Investigational Site
state: Michigan
city: Staten Island
country: United States
facility: Investigational Site
state: New York
city: Madison
country: United States
facility: Investigational Site
state: Tennessee
city: Bellaire
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Bellevue
country: United States
facility: Investigational Site
state: Washington
city: Kirkland
country: United States
facility: Investigational Site
state: Washington
city: West Allis
country: United States
facility: Investigational Site
state: Wisconsin
city: Vienna
country: Austria
facility: Novartis Investigational Site
city: Kelowna
country: Canada
facility: Novartis Investigational Site
city: London
country: Canada
facility: Novartis investigator site
city: Montreal
country: Canada
facility: Novartis investigator site
city: Sudbury
country: Canada
facility: Novartis investigator site
city: Vancouver
country: Canada
facility: Novartis investigator site
city: Verdun
country: Canada
facility: Novartis investigator site
city: Bogota
country: Colombia
facility: Guatemala
city: Medellin
country: Colombia
facility: Guatemala
city: Pareira
country: Colombia
facility: Guatemala
city: Brno
country: Czech Republic
facility: Novartis Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Novartis Investigational Site
city: Prague
country: Czech Republic
facility: Novartis Investigational Site
city: Berlin
country: Germany
facility: Novartis Investigational Site
city: Bochum
country: Germany
facility: Novartis Investigational Site
city: Dresden
country: Germany
facility: Novartis Investigational Site
city: Ingolstadt
country: Germany
facility: Novartis Investigational Site
city: Mannheim
country: Germany
facility: Novartis Investigational Site
city: Wurzburg
country: Germany
facility: Novartis Investigational Site
city: Guatemala city
country: Guatemala
facility: Novartis Investigational Site
city: Lima
country: Peru
facility: Novartis Investigational Site
city: Moscow
country: Russian Federation
facility: Novartis Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigational Site
city: Bojnice
country: Slovakia
facility: Novartis Investigational Site
city: Michalovce
country: Slovakia
facility: Novartis Investigational Site
city: Durban
country: South Africa
facility: Novartis Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: Novartis Investigational Site
city: Kiev
country: Ukraine
facility: Novartis Investigational Site
city: Lugansk
country: Ukraine
facility: Novartis Investigational Site
city: Odessa
country: Ukraine
facility: Novartis Investigational Site
city: Simferopol
country: Ukraine
facility: Novartis Investigational Site
city: Caracas
country: Venezuela
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: