NCT00099229

Brief Summary

This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2004

Geographic Reach
3 countries

22 active sites

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

November 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

December 10, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

December 10, 2004

Last Update Submit

February 21, 2017

Conditions

Bipolar Disorder

Keywords

bipolar disordermanic episodetreatmentlicarbazepine

Outcome Measures

Primary Outcomes (1)

  • Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).

Secondary Outcomes (1)

  • Major improvement in anxiety and depression from baseline to endpoint (Week 3)

Interventions

LicarbazepineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
  • In need of psychiatric treatment
  • Cooperation and willingness to complete all aspects of the study

You may not qualify if:

  • Current diagnosis other than bipolar I disorder
  • History of schizophrenia or schizoaffective disorder
  • Drug dependence within 1 month prior to study start or testing positive in a urine drug test
  • Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
  • Any form of psychotherapy within 1 month prior to study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Investigational Site

Cerritos, California, 90703, United States

Location

Investigational Site

San Diego, California, 92126, United States

Location

Investigational Site

Port Charlotte, Florida, 33952, United States

Location

Investigational Site

Indianapolis, Indiana, 46222, United States

Location

Investigational Site

Newton, Kansas, 67114, United States

Location

Investigational Site

Las Vegas, Nevada, 89103, United States

Location

Investigational Site

Raleigh, North Carolina, 27609, United States

Location

Investigational Site

Cincinnati, Ohio, 45267, United States

Location

Investigational Site

Oklahoma City, Oklahoma, 73118, United States

Location

Investigational Site

Philadelphia, Pennsylvania, 19124, United States

Location

Investigational Site

Austin, Texas, 78756, United States

Location

Investigational Site

Bellaire, Texas, 77401, United States

Location

Investigational Site

Houston, Texas, 77007, United States

Location

Investigational Site

Houston, Texas, 77021, United States

Location

Investigational Site

Kirkland, Washington, 98033, United States

Location

Investigational Site

Dijon, 21033, France

Location

Investigational Site

Strasbourg, 67091, France

Location

Investigational Site

Moscow, 107076, Russia

Location

Investigational Site

Moscow, 113152, Russia

Location

Investigational Site

Moscow, 123367, Russia

Location

Investigational Site

Saint Petersburg, 193019, Russia

Location

Related Links

MeSH Terms

Conditions

Bipolar DisorderMania

Interventions

10,11-dihydro-10-hydroxy-5H-dibenz(b,f)azepine-5-carboxamide

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2004

First Posted

December 10, 2004

Study Start

November 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(16)RU(4)FR(2)