Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
1 other identifier
interventional
343
13 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Typical duration for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 11, 2005
CompletedFirst Posted
Study publicly available on registry
April 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMarch 22, 2017
March 1, 2017
2.8 years
April 11, 2005
March 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).
Secondary Outcomes (1)
Major improvement in anxiety and depression from baseline to endpoint (week 6)
Study Arms (2)
licarbazepine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Investigational Site
La Palma, California, 90623, United States
Investigational Site
Kansas City, Kansas, 66160, United States
Investigational Site
Shreveport, Louisiana, 71101, United States
Investigational Site
Somerville, Massachusetts, 02143, United States
Investigational Site
Farmington Hills, Michigan, 48334, United States
Investigational Site
Staten Island, New York, 10305, United States
Investigational Site
Madison, Tennessee, 37115, United States
Investigational Site
Bellaire, Texas, 77401, United States
Investigational Site
Dallas, Texas, 75235, United States
Investigational Site
Bellevue, Washington, 98004, United States
Investigational Site
Kirkland, Washington, 98033, United States
Investigational Site
West Allis, Wisconsin, 53227, United States
Novartis Investigational Site
Vienna, Austria
Novartis investigator site
Greater Sudbury, Canada
Novartis Investigational Site
Kelowna, Canada
Novartis investigator site
London, Canada
Novartis investigator site
Montreal, Canada
Novartis investigator site
Vancouver, Canada
Novartis investigator site
Verdun, Canada
Guatemala
Bogotá, Colombia
Guatemala
Medellín, Colombia
Guatemala
Pareira, Colombia
Novartis Investigational Site
Brno, Czechia
Novartis Investigational Site
Hradec Králové, Czechia
Novartis Investigational Site
Prague, Czechia
Novartis Investigational Site
Berlin, Germany
Novartis Investigational Site
Bochum, Germany
Novartis Investigational Site
Dresden, Germany
Novartis Investigational Site
Ingolstadt, Germany
Novartis Investigational Site
Mannheim, Germany
Novartis Investigational Site
Würzburg, Germany
Novartis Investigational Site
Guatemala City, Guatemala
Novartis Investigational Site
Lima, Peru
Novartis Investigational Site
Moscow, Russia
Novartis Investigational Site
Yaroslavl, Russia
Novartis Investigational Site
Bojnice, Slovakia
Novartis Investigational Site
Michalovce, Slovakia
Novartis Investigational Site
Durban, South Africa
Novartis Investigational Site
Dnipro, Ukraine
Novartis Investigational Site
Kiev, Ukraine
Novartis Investigational Site
Luhansk, Ukraine
Novartis Investigational Site
Odesa, Ukraine
Novartis Investigational Site
Simferopol, Ukraine
Novartis Investigational Site
Caracas, Venezuela
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 11, 2005
First Posted
April 12, 2005
Study Start
October 1, 2004
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
March 22, 2017
Record last verified: 2017-03