NCT00107939

Brief Summary

The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
453

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

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
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

April 11, 2005

Last Update Submit

March 20, 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 6)

Secondary Outcomes (1)

  • Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.

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, 72201, United States

Location

Investigational Site

Orange, California, 92868, United States

Location

Investigational Site

Pico Rivera, California, 90660, United States

Location

Investigational Site

San Diego, California, 92108, United States

Location

Investigational Site

San Diego, California, 92126, United States

Location

Investigational Site

Boca Raton, Florida, 33432, United States

Location

Investigational Site

Atlanta, Georgia, 30308, United States

Location

Investigational Site

Chicago, Illinois, 60640, United States

Location

Investigational Site

Joliet, Illinois, 60435, United States

Location

Investigational Site

Indianapolis, Indiana, 46222, United States

Location

Investigational Site

Topeka, Kansas, 66606, United States

Location

Investigational Site

Kansas City, Missouri, 64133, United States

Location

Investigational Site

St Louis, Missouri, 63104, United States

Location

Invetigational Site

Brooklyne, New York, 11201, United States

Location

Investigational Site

Cedarhurst, New York, 11516, United States

Location

Investigational Site

New York, New York, 10003, United States

Location

Investigational Site

Cincinnati, Ohio, 45267, United States

Location

Investigational Site

Columbus, Ohio, 43210, United States

Location

Investigational Site

Providence, Rhode Island, 02903, United States

Location

Investigational Site

Bellaire, Texas, 77401, United States

Location

Investigational Site

Bellevue, Washington, 98004, United States

Location

Investigational Site

West Allis, Wisconsin, 53227, United States

Location

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

April 11, 2005

First Posted

April 12, 2005

Study Start

November 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

US(22)