Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
Information source: All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Oxcarbazepine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: All India Institute of Medical Sciences, Bhubaneswar Official(s) and/or principal investigator(s): DEBASISH HOTA, MD, DM, Study Director, Affiliation: AIIMS, Bhubaneswar
Overall contact: RITUPARNA MAITI, MD, Phone: 9438884191, Email: rituparnamaiti@gmail.com
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.
Clinical Details
Official title: Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serum Brain Derived Neurotrophic factor (BDNF)
Secondary outcome: Correlation between Young Mania Rating Scale (YMRS) and Serum Brain Derived Neurotrophic factor (BDNF)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
RITUPARNA MAITI, MD, Phone: 9438884191, Email: rituparnamaiti@gmail.com
All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha 751019, India; Recruiting RITUPARNA MAITI, MD, Phone: 9438884191, Email: rituparnamaiti@gmail.com BISWA R MISHRA, MD, Email: brm1678@gmail.com
Additional Information
Starting date: June 2015
Last updated: June 5, 2015
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