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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT00099229 |
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Date of registration:
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10/12/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
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Scientific title:
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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 |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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320 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00099229 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 3
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Countries of recruitment
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France
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Russian Federation
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bipolar Disorder
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Intervention(s)
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Drug: Licarbazepine
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Primary Outcome(s)
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Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (Week 3).
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Secondary Outcome(s)
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Major improvement in anxiety and depression from baseline to endpoint (Week 3)
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Secondary ID(s)
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CLIC477D2301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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