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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Oxcarbazepine, bipolar disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oxcarbazepine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of bipolar disorder type I or II

Exclusion Criteria

* Other serious medical conditions
* Treatment with antiepileptic medications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eduard Vieta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, Universitary of Barcelona

References

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Vieta E, Cruz N, Garcia-Campayo J, de Arce R, Manuel Crespo J, Valles V, Perez-Blanco J, Roca E, Manuel Olivares J, Morinigo A, Fernandez-Villamor R, Comes M. A double-blind, randomized, placebo-controlled prophylaxis trial of oxcarbazepine as adjunctive treatment to lithium in the long-term treatment of bipolar I and II disorder. Int J Neuropsychopharmacol. 2008 Jun;11(4):445-52. doi: 10.1017/S1461145708008596. Epub 2008 Mar 17.

Reference Type RESULT

PMID: 18346292 (View on PubMed)

Other Identifiers

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CTRI476BES03

Identifier Type: -

Identifier Source: org_study_id