Study of the Effect of Antidepressant Drugs on Neurotrophic Factors in Patients With Depression

NCT03126188 | Completed

• 1 other identifier: T/IM-F/Psych/15/20
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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

Depressive Episode

Outcome Measures

Primary Outcomes (1)

• Change in serum nerve growth factor from baseline over 6 weeks

  ELISA

  Baseline and 6 weeks

Secondary Outcomes (3)

• Change in serum neurotrophin 3 from baseline over 6 weeks

  Baseline and 6 weeks

• Change in serum neurotrophin 4 from baseline over 6 weeks

  Baseline and 6 weeks

• Change in severity of symptoms of depression from baseline over 6 weeks

  Baseline and 6 weeks

Study Arms (3)

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.

Drug: Sertraline

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

Drug: Dosulepin

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.

Drug: Venlafaxine

Interventions

Sertraline DRUG

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 group

Dosulepin DRUG

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.

Dosulepin group

Venlafaxine DRUG

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 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with depression with or without somatic syndrome attending the outpatient department of Psychiatry, AIIMS, Bhubaneswar.

You may qualify if:

• Patients with the diagnosis of Depressive episode (Single episode or recurrent) (by ICD-10 DCR) without psychotic symptoms.
• Patients aged 18-65 years, of either sex.
• Patients with baseline score \> 7 on the Montgomery-Asberg Depression Rating Scale (MADRS).

You may not qualify if:

• Patients with Depressive episode (by ICD-10 DCR) with psychotic symptoms.
• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

Dept of Psychiatry, Aiims, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (10)

• 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.

  PMID: 17173978 RESULT

• 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.

  PMID: 23691270 RESULT

• 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.

  PMID: 11522260 RESULT

• 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.

  PMID: 25897228 RESULT

• 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.

  PMID: 24868159 RESULT

• 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.

  PMID: 11032384 RESULT

• 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.

  PMID: 25290636 RESULT

• 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.

  PMID: 19081579 RESULT

• 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.

  PMID: 25076171 RESULT

• 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.

  PMID: 18174510 RESULT

MeSH Terms

Interventions

Sertraline; Dothiepin; Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzothiepins; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids

Study Officials

• BISWA R MISHRA, MD

  AIIMS, BHUBANESWAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 24, 2017
• Study Start: April 5, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 28, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

IN (1)