NCT00154323

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2003

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

September 8, 2005

Last Update Submit

December 13, 2023

Conditions

Bipolar Disorder

Keywords

Oxcarbazepine, bipolar disorder

Outcome Measures

Primary Outcomes (1)

  • Duration of remission

Secondary Outcomes (5)

  • 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

Interventions

OxcarbazepineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of bipolar disorder type I or II

You may not qualify if:

  • Other serious medical conditions
  • Treatment with antiepileptic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18346292RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Eduard Vieta, MD

    Hospital Clinic, Universitary of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

December 14, 2023

Record last verified: 2023-12