Trial Outcomes & Findings for Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder (NCT NCT02456896)

NCT ID: NCT02456896

Last Updated: 2019-05-07

Results Overview

Serum BDNF was estimated by ELISA using human BDNF ELISA kit from Boster Biological Technology Co. Ltd., Pleasanton, CA.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline and 4 weeks
• Results posted on: 2019-05-07

Participant Flow

June 2015 to December 2015 Psychiatry outpatient department

Out of 40 bipolar mania patients screened, 12 patients were excluded as they did not meet the inclusion criteria and another three patients declined to participate. For recruitment of healthy controls, 35 subjects were screened and after exclusion of 10 subjects, 25 were included in the study.

Participant milestones

Measure	Healthy Control Twenty five (25) age and sex matched healthy individuals served as the control group.	Oxcarbazepine Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks. Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
Overall Study STARTED	25	25
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Healthy Control n=25 Participants Twenty five (25) age and sex matched healthy individuals served as the control group.	Oxcarbazepine n=25 Participants Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks. Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).	Total n=50 Participants Total of all reporting groups
Age, Continuous	34.44 years STANDARD_DEVIATION 9.53 • n=5 Participants	34.16 years STANDARD_DEVIATION 9.89 • n=7 Participants	34.3 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment India	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Serum BDNF was estimated by ELISA using human BDNF ELISA kit from Boster Biological Technology Co. Ltd., Pleasanton, CA.

Outcome measures

Measure	Healthy Control n=19 Participants Twenty five (25) age and sex matched healthy individuals served as the control group.	Oxcarbazepine n=21 Participants Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks. Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
Change in Serum Brain Derived Neurotrophic Factor (BDNF)	23.1 pg/ml Standard Deviation 92.7	90.7 pg/ml Standard Deviation 85.0

SECONDARY outcome

Timeframe: At baseline

Population: At baseline

The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.

Spearman's rank correlation coefficient (Spearman's ρ) was calculated for measuring correlation between YMRS score and serum BDNF.

Outcome measures

Measure	Healthy Control n=25 Participants Twenty five (25) age and sex matched healthy individuals served as the control group.	Oxcarbazepine n=25 Participants Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks. Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
Correlation Between Young Mania Rating Scale (YMRS) and Serum Brain Derived Neurotrophic Factor (BDNF)	-0.59 Spearman's ρ	-0.59 Spearman's ρ

Adverse Events

Healthy Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oxcarbazepine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rituparna Maiti

AIIMS, Bhubaneswar, India

Phone: 9438884191

Email: rituparnamaiti@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place