Phase 4
Completed N=50
Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
Source: ClinicalTrials.gov NCT02456896 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Change in Serum Brain Derived Neurotrophic Factor (BDNF) — 23.1; 90.7 pg/ml
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Brain Derived Neurotrophic Factor (BDNF) |
23.1; 90.7 | — |
| SECONDARY Correlation Between Young Mania Rating Scale (YMRS) and Serum Brain Derived Neurotrophic Factor (BDNF) |
-0.59; -0.59 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02456896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.