Ignite Creation Date:
2024-05-06 @ 4:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02456896
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2015-05-27
Brief Title:
Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor BDNF in Bipolar Disorder
Sponsor:
All India Institute of Medical Sciences Bhubaneswar
Organization:
All India Institute of Medical Sciences Bhubaneswar
Study Overview
Official Title:
Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor BDNF in Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None