Back to resultsThe 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.
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxcarbazepine
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Oxcarbazepine, bipolar disorder
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00154323
Brief Title
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.
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Oxcarbazepine, bipolar disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Primary Outcome Measure Information:
Title
Duration of remission
Secondary Outcome Measure Information:
Title
Daily mood fluctuation
Title
Time to new maniac/hypomanic episode
Title
Time to new depressive episode
Title
Number of relapsed patients at study completion and type/severity of episode
Title
Change from baseline in functional activity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Vieta, MD
Organizational Affiliation
Hospital Clinic, Universitary of Barcelona
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
18346292
Citation
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.
Results Reference
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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.
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