search
Back to results

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
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
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
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2004
Last Updated
February 21, 2017
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00099229
Brief Title
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Tolerability of Licarbazepine 1000-2000mg/Day in the Treatment of Manic Episodes of Bipolar I Disorder Over 3 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

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
Double
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Licarbazepine
Primary Outcome Measure Information:
Title
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).
Secondary Outcome Measure Information:
Title
Major improvement in anxiety and depression from baseline to endpoint (Week 3)

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
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92126
Country
United States
Facility Name
Investigational Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
Facility Name
Investigational Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Investigational Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
Facility Name
Investigational Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
Facility Name
Investigational Site
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
113152
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
123367
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
193019
Country
Russian Federation

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

We'll reach out to this number within 24 hrs