The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.

This study has been completed.

First Received on September 8, 2005. Last Updated on November 22, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00154323

Purpose

Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Oxcarbazepine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled 52 Weeks Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o.(300-1200 mg/Day) as Adjuvant Therapy in the Bipolar Disorder I or II Treatment

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Oxcarbazepine

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Duration of remission

Secondary Outcome Measures:

Daily mood fluctuation
Time to new maniac/hypomanic episode
Time to new depressive episode
Number of relapsed patients at study completion and type/severity of episode
Change from baseline in functional activity

Enrollment:	55
Study Start Date:	January 2003
Study Completion Date:	January 2006
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

History of bipolar disorder type I or II

Exclusion Criteria:

Other serious medical conditions
Treatment with antiepileptic medications

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154323

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Eduard Vieta, MD

Hospital Clinic, Universitary of Barcelona

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00154323 History of Changes
Other Study ID Numbers:	CTRI476BES03
Study First Received:	September 8, 2005
Last Updated:	November 22, 2011
Health Authority:	Spain: Ministry of Health

Keywords provided by Novartis:

Oxcarbazepine, bipolar disorder

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012