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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00107926
Collaborator
(none)
343
Enrollment
44
Locations
2
Arms
34
Duration (Months)
7.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
343 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Aug 1, 2007
Actual Study Completion Date :
Aug 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: licarbazepine

Drug: Licarbazepine
Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Major improvement in anxiety and depression from baseline to endpoint (week 6) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational Site La Palma California United States 90623
2 Investigational Site Kansas City Kansas United States 66160
3 Investigational Site Shreveport Louisiana United States 71101
4 Investigational Site Somerville Massachusetts United States 02143
5 Investigational Site Farmington Hills Michigan United States 48334
6 Investigational Site Staten Island New York United States 10305
7 Investigational Site Madison Tennessee United States 37115
8 Investigational Site Bellaire Texas United States 77401
9 Investigational Site Dallas Texas United States 75235
10 Investigational Site Bellevue Washington United States 98004
11 Investigational Site Kirkland Washington United States 98033
12 Investigational Site West Allis Wisconsin United States 53227
13 Novartis Investigational Site Vienna Austria
14 Novartis Investigational Site Kelowna Canada
15 Novartis investigator site London Canada
16 Novartis investigator site Montreal Canada
17 Novartis investigator site Sudbury Canada
18 Novartis investigator site Vancouver Canada
19 Novartis investigator site Verdun Canada
20 Guatemala Bogota Colombia
21 Guatemala Medellin Colombia
22 Guatemala Pareira Colombia
23 Novartis Investigational Site Brno Czech Republic
24 Novartis Investigational Site Hradec Kralove Czech Republic
25 Novartis Investigational Site Prague Czech Republic
26 Novartis Investigational Site Berlin Germany
27 Novartis Investigational Site Bochum Germany
28 Novartis Investigational Site Dresden Germany
29 Novartis Investigational Site Ingolstadt Germany
30 Novartis Investigational Site Mannheim Germany
31 Novartis Investigational Site Wurzburg Germany
32 Novartis Investigational Site Guatemala city Guatemala
33 Novartis Investigational Site Lima Peru
34 Novartis Investigational Site Moscow Russian Federation
35 Novartis Investigational Site Yaroslavl Russian Federation
36 Novartis Investigational Site Bojnice Slovakia
37 Novartis Investigational Site Michalovce Slovakia
38 Novartis Investigational Site Durban South Africa
39 Novartis Investigational Site Dnepropetrovsk Ukraine
40 Novartis Investigational Site Kiev Ukraine
41 Novartis Investigational Site Lugansk Ukraine
42 Novartis Investigational Site Odessa Ukraine
43 Novartis Investigational Site Simferopol Ukraine
44 Novartis Investigational Site Caracas Venezuela

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00107926
Other Study ID Numbers:
  • CLIC477D2303
First Posted:
Apr 12, 2005
Last Update Posted:
Mar 22, 2017
Last Verified:
Mar 1, 2017
Keywords provided by , ,
bipolar disorder
manic episode
treatment
licarbazepine
Additional relevant MeSH terms:
Mania
Disease
Bipolar Disorder

Study Results

No Results Posted as of Mar 22, 2017