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

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ClinicalTrials.gov Identifier: NCT02456896
Recruitment Status : Completed
First Posted : May 29, 2015
Results First Posted : April 15, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Oxcarbazepine Phase 4

Detailed Description:

Bipolar disorder (BD) is a chronic psychiatric illness of partially unknown pathophysiology. BD likely involves, at a molecular and cellular level, dysfunctions of critical neurotrophic, cellular plasticity and resilience pathways and neuroprotective processes. Abnormalities of neurotrophins (NTs) and other trophic factors orchestrate important alterations which could be implicated in the etiology of BD. As consistently reported in post-mortem studies, these modifications are generally associated with the disruption of distinct subregions and functions of the brain, one of which is the deregulation of neurotrophins.

NTs are capable of signaling neurons, glial cells and other cellular systems to enable survival, differentiation and growth. BDNF is one of the most studied and abundant NTs in the brain, which plays an important role in a variety of neural processes during the development of both animals and humans. Initially, BDNF is important for neurogenesis, neuronal survival, and normal maturation of neural development pathways. In the adult, BDNF is not only important for synaptic plasticity and dendritic growth, but also for long-term memory consolidation. Several studies have proved that BDNF is significantly reduced in manic, hypomanic or depressive stages of BD, whereas euthymic patients exhibit BDNF levels similar to healthy controls.

Rafael T. de Sousa et al have observed a significant increase in serum BDNF levels after 28 days of lithium monotherapy in patients with BD and suggested neuroprotective role of lithium due to its direct regulatory effect on BDNF. Oxcarbazepine is a commonly used mood stabilizer which has demonstrated comparable efficacy to divalproate sodium and better tolerability profile but till date there is no study on its effect on BDNF. The aim of the present study is to evaluate the change in serum BDNF level with oxcarbazepine monotherapy in bipolar disorder and to explore the possibility of its neuroprotective effect.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
Study Start Date : June 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
No Intervention: Healthy control
Twenty five (25) age and sex matched healthy individuals will serve as the control group. Control subjects will be evaluated at baseline only.
Experimental: Oxcarbazepine
Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.
Drug: 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).




Primary Outcome Measures :
  1. Change in Serum Brain Derived Neurotrophic Factor (BDNF) [ Time Frame: Baseline and 4 weeks ]
    Serum BDNF was estimated by ELISA using human BDNF ELISA kit from Boster Biological Technology Co. Ltd., Pleasanton, CA.


Secondary Outcome Measures :
  1. Correlation Between Young Mania Rating Scale (YMRS) and Serum Brain Derived Neurotrophic Factor (BDNF) [ Time Frame: 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.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456896


Locations
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India
All India Institute of Medical Sciences (AIIMS)
Bhubaneswar, Odisha, India, 751019
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Investigators
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Study Director: DEBASISH HOTA, MD, DM AIIMS, Bhubaneswar

Publications:

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Responsible Party: RITUPARNA MAITI, Associate Professor, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT02456896     History of Changes
Other Study ID Numbers: T/IM-NF/Pharm/14/19
First Posted: May 29, 2015    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019

Keywords provided by RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar:
Oxcarbazepine
Brain Derived Neurotrophic Factor
Bipolar disorder
Neuroprotection

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Oxcarbazepine
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers