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

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT00107926

Run by

Novartis Pharmaceuticals

People needed

343

Starts

2004-10-01

Expected to finish

2007-08-01

Last updated by the study team

2017-03-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Investigational Site — La Palma, California, United States
• Investigational Site — Kansas City, Kansas, United States
• Investigational Site — Shreveport, Louisiana, United States
• Investigational Site — Somerville, Massachusetts, United States
• Investigational Site — Farmington Hills, Michigan, United States
• Investigational Site — Staten Island, New York, United States
• Investigational Site — Madison, Tennessee, United States
• Investigational Site — Bellaire, Texas, United States
• Investigational Site — Dallas, Texas, United States
• Investigational Site — Bellevue, Washington, United States
• Investigational Site — Kirkland, Washington, United States
• Investigational Site — West Allis, Wisconsin, 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

Full record on ClinicalTrials.gov

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