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

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ClinicalTrials.gov Identifier: NCT00107926
Recruitment Status : Completed
First Posted : April 12, 2005
Last Update Posted : March 22, 2017
Sponsor:
Information provided by:
Novartis

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
Bipolar Disorder Drug: Licarbazepine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
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 : October 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: licarbazepine Drug: Licarbazepine
Placebo Comparator: Placebo Drug: Placebo



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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107926


  Show 44 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
ClinicalTrials.gov Identifier: NCT00107926     History of Changes
Other Study ID Numbers: CLIC477D2303
First Posted: April 12, 2005    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Novartis:
bipolar disorder
manic episode
treatment
licarbazepine

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders