Overview

Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
The present study has been designed to evaluate the change in serum BDNF level with oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its neuroprotective effect.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Treatments:
Carbamazepine
Oxcarbazepine
Criteria
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.