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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00154323
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Disorder Drug: Oxcarbazepine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2003
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Primary Outcome Measures :
  1. Duration of remission

Secondary Outcome Measures :
  1. Daily mood fluctuation
  2. Time to new maniac/hypomanic episode
  3. Time to new depressive episode
  4. Number of relapsed patients at study completion and type/severity of episode
  5. Change from baseline in functional activity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00154323

Sponsors and Collaborators
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Principal Investigator: Eduard Vieta, MD Hospital Clinic, Universitary of Barcelona

Additional Information:
Publications of Results:
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Responsible Party: Novartis Identifier: NCT00154323     History of Changes
Other Study ID Numbers: CTRI476BES03
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Oxcarbazepine, bipolar disorder

Additional relevant MeSH terms:
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Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers