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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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12 December 2020 |
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Main ID: |
NCT02456896 |
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Date of registration:
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27/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
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Scientific title:
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Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02456896 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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DEBASISH HOTA, MD, DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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AIIMS, Bhubaneswar |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All patients with the diagnosis of bipolar affective disorder (by ICD-10 DCR) current
episode mania without psychotic symptoms
- Patients aged 18-45 years, of either sex.
- Patients with baseline score > 20 on the Young Mania Rating Scale (YMRS).
- Patients who had not taken any treatment for at least 4 weeks before inclusion.
Exclusion Criteria:
- Patients with bipolar disorder (by ICD-10 DCR) presenting during
depressive/euthymic/mixed episode.
- Patients who are already under treatment for the presenting conditions.
- Rapid cycling in the past 12 months.
- Previous history of refractoriness to carbazepine or oxcarbazepine.
- Patients with comorbid substance abuse or history of organicity
- Pregnant and nursing women, patients with history of major medical or neurological
illness.
Age minimum:
18 Years
Age maximum:
45 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: Oxcarbazepine
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Primary Outcome(s)
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Change in Serum Brain Derived Neurotrophic Factor (BDNF)
[Time Frame: Baseline and 4 weeks]
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Secondary Outcome(s)
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Correlation Between Young Mania Rating Scale (YMRS) and Serum Brain Derived Neurotrophic Factor (BDNF)
[Time Frame: At baseline]
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Secondary ID(s)
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T/IM-NF/Pharm/14/19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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