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Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Licarbazepine
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, manic episode, treatment, licarbazepine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis investigator site
  • Novartis investigator site
  • Novartis investigator site
  • Novartis investigator site
  • Novartis investigator site
  • Guatemala
  • Guatemala
  • Guatemala
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site
  • Novartis Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

licarbazepine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).

Secondary Outcome Measures

Major improvement in anxiety and depression from baseline to endpoint (week 6)

Full Information

First Posted
April 11, 2005
Last Updated
March 20, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00107926
Brief Title
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Official Title
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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 treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
bipolar disorder, manic episode, treatment, licarbazepine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
licarbazepine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Licarbazepine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).
Secondary Outcome Measure Information:
Title
Major improvement in anxiety and depression from baseline to endpoint (week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Investigational Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Investigational Site
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02143
Country
United States
Facility Name
Investigational Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Investigational Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Investigational Site
City
Madison
State/Province
Tennessee
ZIP/Postal Code
37115
Country
United States
Facility Name
Investigational Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Investigational Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Investigational Site
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Novartis Investigational Site
City
Vienna
Country
Austria
Facility Name
Novartis Investigational Site
City
Kelowna
Country
Canada
Facility Name
Novartis investigator site
City
London
Country
Canada
Facility Name
Novartis investigator site
City
Montreal
Country
Canada
Facility Name
Novartis investigator site
City
Sudbury
Country
Canada
Facility Name
Novartis investigator site
City
Vancouver
Country
Canada
Facility Name
Novartis investigator site
City
Verdun
Country
Canada
Facility Name
Guatemala
City
Bogota
Country
Colombia
Facility Name
Guatemala
City
Medellin
Country
Colombia
Facility Name
Guatemala
City
Pareira
Country
Colombia
Facility Name
Novartis Investigational Site
City
Brno
Country
Czech Republic
Facility Name
Novartis Investigational Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Novartis Investigational Site
City
Prague
Country
Czech Republic
Facility Name
Novartis Investigational Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigational Site
City
Bochum
Country
Germany
Facility Name
Novartis Investigational Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigational Site
City
Ingolstadt
Country
Germany
Facility Name
Novartis Investigational Site
City
Mannheim
Country
Germany
Facility Name
Novartis Investigational Site
City
Wurzburg
Country
Germany
Facility Name
Novartis Investigational Site
City
Guatemala city
Country
Guatemala
Facility Name
Novartis Investigational Site
City
Lima
Country
Peru
Facility Name
Novartis Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Novartis Investigational Site
City
Bojnice
Country
Slovakia
Facility Name
Novartis Investigational Site
City
Michalovce
Country
Slovakia
Facility Name
Novartis Investigational Site
City
Durban
Country
South Africa
Facility Name
Novartis Investigational Site
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Kiev
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Lugansk
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Odessa
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Simferopol
Country
Ukraine
Facility Name
Novartis Investigational Site
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com/etrials/DiseaseID10/Bipolar-Disorder-clinical-trials.go
Description
Click here for further information and to find an investigational site near you

Learn more about this trial

Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

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