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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
United States
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
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  • Invetigational Site
  • Investigational Site
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  • Investigational Site
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Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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
NCT00107939
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, Safety and Tolerability of Licarbazepine 750 ¿ 2000 mg/d as Adjunctive Therapy to an Atypical Antipsychotic in the Treatment of Manic Episodes of Bipolar I Disorder Over 6 Weeks
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 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.

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
453 (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 6)
Secondary Outcome Measure Information:
Title
Safety and tolerability of treatment with licarbazepine over 6 weeks, with respect to adverse events and SAEs, laboratory values, ECGs and vital signs.

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
72201
Country
United States
Facility Name
Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
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
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Investigational Site
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
Facility Name
Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Invetigational Site
City
Brooklyne
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Investigational Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Investigational Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Investigational Site
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States

12. IPD Sharing Statement

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

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