Study of the Effect of Antidepressant Drugs on Neurotrophic Factors in Patients With Depression
NCT ID: NCT03126188
Last Updated: 2018-07-11
Study Results
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Basic Information
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COMPLETED
105 participants
OBSERVATIONAL
2017-04-05
2018-02-28
Brief Summary
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Detailed Description
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In context to Neurotropic hypothesis, in depression there is reduction in Neurotrophins (NTs), which impairs the pruning of the neural network, alters neural plasticity, and impacts negatively on the structural and functional processes within the limbic system. NTs in general and Brain Derived Neurotrophic Factor (BDNF) in particular modulate depressive behavior and the response to antidepressant treatment, in part through the regulation of synaptic plasticity, synaptogenesis, and neurogenesis. Major neurotrophins like nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), neurotrophin-3 (NT-3) and neurotrophin-4/5 (NT-4/5) have been identified in context to nervous system functioning.
Previous studies have consistently proved the reduction in BDNF levels in patients with depression and antidepressants were found to increase BDNF protein levels with re-establishment of normative cortical networks in different areas of hippocampus. Recent studies have provided important links between the neurobiological characteristics of depression and NGF. Animal studies have revealed decreasing levels of NGF in specific brain areas of different mouse models, including anxiety vulnerability, stress-induced illness, and learned helplessness. In relation to the patients with depression, NGF has been recognized as an important factor in modulating their altered or dysfunctional hypothalamic-pituitary-adrenal (HPA) axis. Previous studies have compared the differences in peripheral NGF levels in patients with depression and healthy controls, others have investigated the effect of different treatments on their levels. The results have been conflicting in relation to NGF levels results before and after antidepressant treatment in patients with depression, thus, necessitating the need for further research in this area.
Studies related to NT-3 levels in unipolar depression is limited, when researchers have reported of increased CSF levels of NT-3 in elderly depressed patients and increased serum NT-3 levels in the depressive phase of Bipolar disorder. Lower level of neurotrophins like BDNF, but higher level of NT-3, have been found in depressed patients with schizophrenia. NT-4 has been a potential candidate neurotropic factor for research in patients with mood disorder. Studies have reported of increased serum NT-4 levels in the depressive phase of Bipolar disorder, when others have found the increase in serum NT-4 levels in both the depressive and manic phases of the illness. Contrastingly, studies have also found reduction in NT-4 levels in the manic phase of Bipolar disorder.
The literature search clearly reveals the lack of studies or inconsistent findings in relation to the role of major NTs like NGF, Neurotrophin-3, and Neurotrophin-4 in unipolar depression. It will be worth studying the changes in these NTs in depression and the effect of various antidepressants on their levels, this can help us in understanding the caveats in pathophysiology of depression better, which can have future treatment implications.
The aim of the present study will be to observe the changes in the NTs like Nerve growth factor, Neurotrophin-3, and Neurotrophin-4 in patients with depression and study the effect of various antidepressants like Sertraline (SSRI), Dosulepin (TCA), and Venlafaxine (SNRI) on their levels.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sertraline group
Mild and Moderate depressive episode without somatic syndrome who are treated with Sertraline. Tab. Sertraline 50 mg/day, which will be optimized to 75mg/day after 2 weeks if required, and maintained on the same dose for a minimum period of 6 weeks.
Sertraline
Tab. Sertraline 50 mg/day, which will be optimized to 75mg/day after 2 weeks if required, and maintained on the same dose for a minimum period of 6 weeks.
Dosulepin group
Mild and Moderate depressive episode with somatic syndrome who were treated with Dosulepin. Tab. Dosulepin 25mg/day, which will be gradually hiked up to 75mg/day over 2 weeks
Dosulepin
Tab. Dosulepin 25mg/day, which will be gradually hiked up to 75mg/day over 2 weeks,and the patients will be continued on the same dose for a minimum period of 6 weeks.
Venlafaxine group
Severe depressive episode without psychotic symptoms who were treated with Venlafaxine. Tab. Venlafaxine 75mg/day, which will be hiked to 112.5 mg/day after 2 weeks, and the patients will be continued on the same dose for a minimum period of 6 weeks.
Venlafaxine
Tab. Venlafaxine 75mg/day, which will be hiked to 112.5 mg/day after 2 weeks, and the patients will be continued on the same dose for a minimum period of 6 weeks.
Interventions
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Sertraline
Tab. Sertraline 50 mg/day, which will be optimized to 75mg/day after 2 weeks if required, and maintained on the same dose for a minimum period of 6 weeks.
Dosulepin
Tab. Dosulepin 25mg/day, which will be gradually hiked up to 75mg/day over 2 weeks,and the patients will be continued on the same dose for a minimum period of 6 weeks.
Venlafaxine
Tab. Venlafaxine 75mg/day, which will be hiked to 112.5 mg/day after 2 weeks, and the patients will be continued on the same dose for a minimum period of 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* Patients aged 18-65 years, of either sex.
* Patients with baseline score \> 7 on the Montgomery-Asberg Depression Rating Scale (MADRS).
* Treatment naïve or patients who had not taken any treatment for at least 4 weeks before inclusion.
Exclusion Criteria
* Patients with Bipolar depression or with Persistent mood disorder (Dysthymia/ Cyclothymia)
* Patients who are already under treatment for the presenting conditions.
* Previous history of refractoriness to SSRI, TCA, or SNRI.
* Patients with comorbid substance abuse or history of organicity
* Patients with history of major medical or neurological illness.
* Pregnant and nursing women.
18 Years
65 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences, Bhubaneswar
OTHER
Responsible Party
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BISWA RANJAN MISHRA
Associate Professor
Principal Investigators
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BISWA R MISHRA, MD
Role: PRINCIPAL_INVESTIGATOR
AIIMS, BHUBANESWAR
Locations
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Dept of Psychiatry, Aiims, Bhubaneswar
Bhubaneswar, Odisha, India
Countries
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References
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Lee BH, Kim H, Park SH, Kim YK. Decreased plasma BDNF level in depressive patients. J Affect Disord. 2007 Aug;101(1-3):239-44. doi: 10.1016/j.jad.2006.11.005. Epub 2006 Dec 13.
Jiang C, Salton SR. The Role of Neurotrophins in Major Depressive Disorder. Transl Neurosci. 2013 Mar 1;4(1):46-58. doi: 10.2478/s13380-013-0103-8.
Chen B, Dowlatshahi D, MacQueen GM, Wang JF, Young LT. Increased hippocampal BDNF immunoreactivity in subjects treated with antidepressant medication. Biol Psychiatry. 2001 Aug 15;50(4):260-5. doi: 10.1016/s0006-3223(01)01083-6.
Chen YW, Lin PY, Tu KY, Cheng YS, Wu CK, Tseng PT. Significantly lower nerve growth factor levels in patients with major depressive disorder than in healthy subjects: a meta-analysis and systematic review. Neuropsychiatr Dis Treat. 2015 Apr 1;11:925-33. doi: 10.2147/NDT.S81432. eCollection 2015.
Liu X, Zhang T, He S, Hong B, Peng D, Su H, Li F, Tang Y, Lin Z, Fang Y, Jiang K. Nerve growth factor variations in patients with mood disorders: no changes in eight weeks of clinical treatment. Neuropsychiatr Dis Treat. 2014 May 15;10:835-40. doi: 10.2147/NDT.S62741. eCollection 2014.
Hock C, Heese K, Muller-Spahn F, Huber P, Riesen W, Nitsch RM, Otten U. Increased cerebrospinal fluid levels of neurotrophin 3 (NT-3) in elderly patients with major depression. Mol Psychiatry. 2000 Sep;5(5):510-3. doi: 10.1038/sj.mp.4000743.
Loch AA, Zanetti MV, de Sousa RT, Chaim TM, Serpa MH, Gattaz WF, Teixeira AL, Machado-Vieira R. Elevated neurotrophin-3 and neurotrophin 4/5 levels in unmedicated bipolar depression and the effects of lithium. Prog Neuropsychopharmacol Biol Psychiatry. 2015 Jan 2;56:243-6. doi: 10.1016/j.pnpbp.2014.09.014. Epub 2014 Oct 5.
Walz JC, Magalhaes PV, Giglio LM, Cunha AB, Stertz L, Fries GR, Andreazza AC, Kapczinski F. Increased serum neurotrophin-4/5 levels in bipolar disorder. J Psychiatr Res. 2009 Apr;43(7):721-3. doi: 10.1016/j.jpsychires.2008.10.005. Epub 2008 Dec 10.
Barbosa IG, Morato IB, Huguet RB, Rocha FL, Machado-Vieira R, Teixeira AL. Decreased plasma neurotrophin-4/5 levels in bipolar disorder patients in mania. Braz J Psychiatry. 2014 Oct-Dec;36(4):340-3. doi: 10.1590/1516-4446-2014-1380. Epub 2014 Jul 29.
Williams JB, Kobak KA. Development and reliability of a structured interview guide for the Montgomery Asberg Depression Rating Scale (SIGMA). Br J Psychiatry. 2008 Jan;192(1):52-8. doi: 10.1192/bjp.bp.106.032532.
Other Identifiers
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T/IM-F/Psych/15/20
Identifier Type: -
Identifier Source: org_study_id
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