- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00154323
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.
December 13, 2023 updated by: Novartis
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Duration of remission
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eduard Vieta, MD, Hospital Clinic, Universitary of Barcelona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimated)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Mood Disorders
- Bipolar and Related Disorders
- Bipolar Disorder
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Oxcarbazepine
Other Study ID Numbers
- CTRI476BES03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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