NCT02456896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

May 7, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

May 27, 2015

Results QC Date

June 27, 2017

Last Update Submit

April 26, 2019

Conditions

Bipolar Disorder

Keywords

OxcarbazepineBrain Derived Neurotrophic FactorBipolar disorderNeuroprotection

Outcome Measures

Primary Outcomes (1)

  • Change in Serum Brain Derived Neurotrophic Factor (BDNF)

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

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Correlation Between Young Mania Rating Scale (YMRS) and Serum Brain Derived Neurotrophic Factor (BDNF)

    At baseline

Study Arms (2)

Healthy control

NO INTERVENTION

Twenty five (25) age and sex matched healthy individuals will serve as the control group. Control subjects will be evaluated at baseline only.

Oxcarbazepine

EXPERIMENTAL

Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.

Drug: Oxcarbazepine

Interventions

OxcarbazepineDRUG

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).

Oxcarbazepine

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences (AIIMS)

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (9)

  • Frey BN, Andreazza AC, Houenou J, Jamain S, Goldstein BI, Frye MA, Leboyer M, Berk M, Malhi GS, Lopez-Jaramillo C, Taylor VH, Dodd S, Frangou S, Hall GB, Fernandes BS, Kauer-Sant'Anna M, Yatham LN, Kapczinski F, Young LT. Biomarkers in bipolar disorder: a positional paper from the International Society for Bipolar Disorders Biomarkers Task Force. Aust N Z J Psychiatry. 2013 Apr;47(4):321-32. doi: 10.1177/0004867413478217. Epub 2013 Feb 14.

    PMID: 23411094BACKGROUND

  • Mufson EJ, Kroin JS, Sendera TJ, Sobreviela T. Distribution and retrograde transport of trophic factors in the central nervous system: functional implications for the treatment of neurodegenerative diseases. Prog Neurobiol. 1999 Feb;57(4):451-84. doi: 10.1016/s0301-0082(98)00059-8.

    PMID: 10080385BACKGROUND

  • Huang EJ, Reichardt LF. Neurotrophins: roles in neuronal development and function. Annu Rev Neurosci. 2001;24:677-736. doi: 10.1146/annurev.neuro.24.1.677.

    PMID: 11520916BACKGROUND

  • Kaplan DR, Miller FD. Neurotrophin signal transduction in the nervous system. Curr Opin Neurobiol. 2000 Jun;10(3):381-91. doi: 10.1016/s0959-4388(00)00092-1.

    PMID: 10851172BACKGROUND

  • Post RM. Role of BDNF in bipolar and unipolar disorder: clinical and theoretical implications. J Psychiatr Res. 2007 Dec;41(12):979-90. doi: 10.1016/j.jpsychires.2006.09.009. Epub 2007 Jan 18.

    PMID: 17239400BACKGROUND

  • Cunha AB, Frey BN, Andreazza AC, Goi JD, Rosa AR, Goncalves CA, Santin A, Kapczinski F. Serum brain-derived neurotrophic factor is decreased in bipolar disorder during depressive and manic episodes. Neurosci Lett. 2006 May 8;398(3):215-9. doi: 10.1016/j.neulet.2005.12.085. Epub 2006 Feb 9.

    PMID: 16480819BACKGROUND

  • Fernandes BS, Gama CS, Cereser KM, Yatham LN, Fries GR, Colpo G, de Lucena D, Kunz M, Gomes FA, Kapczinski F. Brain-derived neurotrophic factor as a state-marker of mood episodes in bipolar disorders: a systematic review and meta-regression analysis. J Psychiatr Res. 2011 Aug;45(8):995-1004. doi: 10.1016/j.jpsychires.2011.03.002. Epub 2011 May 6.

    PMID: 21550050BACKGROUND

  • de Sousa RT, van de Bilt MT, Diniz BS, Ladeira RB, Portela LV, Souza DO, Forlenza OV, Gattaz WF, Machado-Vieira R. Lithium increases plasma brain-derived neurotrophic factor in acute bipolar mania: a preliminary 4-week study. Neurosci Lett. 2011 Apr 20;494(1):54-6. doi: 10.1016/j.neulet.2011.02.054. Epub 2011 Mar 6.

    PMID: 21362460BACKGROUND

  • Kakkar AK, Rehan HS, Unni KE, Gupta NK, Chopra D, Kataria D. Comparative efficacy and safety of oxcarbazepine versus divalproex sodium in the treatment of acute mania: a pilot study. Eur Psychiatry. 2009 Apr;24(3):178-82. doi: 10.1016/j.eurpsy.2008.12.014. Epub 2009 Mar 25.

    PMID: 19324530BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CarbamazepineDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Rituparna Maiti
Organization
AIIMS, Bhubaneswar, India
rituparnamaiti@gmail.com
9438884191

Study Officials

  • DEBASISH HOTA, MD, DM

    AIIMS, Bhubaneswar

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 27, 2015

First Posted

May 29, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 7, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-04

Locations

IN(1)