Neurobiological and Genomic Predictors of Relapse in Depression

NCT07328373 | Recruiting

• 1 other identifier: WSM_MDD
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to test whether the discontinuation of antidepressant medications for patients with depression can be decided after the normalization of biological parameters. The main questions it aims are:

• Undergo quantitative electroencephalography (qEEG),
• Record Event-related potential (ERP),
• Record Sleep EEG
• Answer Hamilton Depression Rating Scale question their psychiatrists asked
• Give blood sample for genetic analysis
• Repeat the above mentioned procedures for at least 3 times during their treatment period. Researchers will compare the results of patients with the results of healthy controls.

Conditions

Healthy; Major Depressive Disorder (MDD)

Keywords

Quantitative EEG; Rapid Eye Movement; Sleep EEG; Event Related Potential; P300; Alpha Asymmetry; Oddball Paradigm; relapse; recurrence; antidepressants; dna; rna; epigenetic; ssri; snri; methylation; quality of life; stress; magnetic resonance imaging; diffusion tensor imaging

Outcome Measures

Primary Outcomes (1)

• Relapse rate

  The number of person relapsed, which is evaluated by Hamilton Depression Rating Scale, after discontinuation of antidepressant treatment.

  From the discontinuation of antidepressant treatment to the first relapse within 6-12 months.

Secondary Outcomes (28)

• Severity of Depression - Baseline (T0)

  Baseline - T0: Before the start of antidepressant medication.

• Severity of Depression - Treatment Response (T1)

  T1: 4-8 weeks after the start of antidepressant treatment (T0)

• Severity of Depression - End of Treatment (T2)

  T2: 6-12 months after the start of antidepressant medication(T0).

• Severity of Depression - End of Study (T3)

  T3: 6-12 months after the discontinuation of treatment(T2)

• QEEG absolute power- Baseline (T0)

  Baseline (Day 0) - T0 (Patients): Before the start of antidepressant medication. Baseline (Day 0) - T0 (Controls): For the control group, this assessment is conducted at the end of initial psychiatric evaluation to establish baseline measurements.

Other Outcomes (14)

• Anxiety Level at Baseline (T0)

  Baseline - T0: Before the start of antidepressant medication.

• Anxiety Level at Treatment Response(T1)

  T1: 4-8 weeks after the start of antidepressant treatment (T0)

• Anxiety level - End of Treatment (T2)

  T2: 6-12 months after the start of antidepressant medication (T0)

Study Arms (5)

Depression-Relapsed Prospectively Followed

This cohort includes patients whose long-term outcome is unknown at the start of the study. They are enrolled, treated, and monitored over time. At the study's conclusion, they will be retrospectively categorized as "Relapsers".

Drug: Antidepressant Medications

Healthy Control

This group is composed of individuals with no history of psychiatric illness. Data is collected at a single time point to establish a healthy baseline for all biomarkers.

Recurrent Depression Retrospectively Defined

Group A (Retrospective / Known Phenotype): This group consists of patients with a confirmed history of recurrent depression. Recurrence defined as no relapse within 1 year after discontinuation of medication. Data for this group is collected at a single time point (Baseline/T0).

Drug: Antidepressant Medications

Non-Recurrent Depression Retrospectively Defined

This group consists of patients with a confirmed history of a single depressive episode or no relapse within 1 year after discontinuation of medication. Data for this group is collected at a single time point (Baseline/T0).

Depression-Non-Relapsers Prospectively Followed

This cohort includes patients whose long-term outcome is unknown at the start of the study. They are enrolled, treated, and monitored over time. At the study's conclusion, they will be retrospectively "Non-Relapsers" (in Remission).

Drug: Antidepressant Medications

Interventions

Antidepressant Medications DRUG

Second generation antidepressants under "selective serotonin reuptake inhibitor" group

Also known as: Selective Serotonin Reuptake Inhibitors, e.g., paroxetine, fluoxetine, sertraline, escitalopram, Selective Norepinephrine Reuptake Inhibitors, e.g., duloxetine, venlafaxine, Atypical Antidepressants, e.g., bupropion, mirtazapine, trazodone

Depression-Non-Relapsers Prospectively Followed; Depression-Relapsed Prospectively Followed; Recurrent Depression Retrospectively Defined

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who get diagnosed with major depressive disorders according to DSM-IV or DSM-V

You may qualify if:

• Outpatients
• For patients, satisfying Major Depressive Disorder for Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR)
• Drug-free for at least 1-week

You may not qualify if:

• Any neurological and psychiatric comorbid conditions
• Hearing loss
• Physical diseases

Sponsors & Collaborators

• Mehmet Kemal Arikan: lead

Study Sites (1)

Prof. Dr. Kemal Arıkan's Psychiatry Clinic

Istanbul, 34380, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Arikan MK, Ilhan R, Pogarell O, Metin B. When to stop medication in unipolar depression: A systematic review and a meta-analysis of randomized controlled trials. J Affect Disord. 2023 Mar 15;325:7-13. doi: 10.1016/j.jad.2023.01.024. Epub 2023 Jan 6.

  PMID: 36623560 BACKGROUND

• Arikan MK, Uysal O, Gica S, Orhan O, Ilhan R, Esmeray MT, Bakay H, Metin B, Pogarell O, Turan S. REM parameters in drug-free major depressive disorder: A systematic review and meta-analysis. Sleep Med Rev. 2024 Feb;73:101876. doi: 10.1016/j.smrv.2023.101876. Epub 2023 Nov 20.

  PMID: 37995418 BACKGROUND

• Arikan MK, Ilhan R, Orhan O, Esmeray MT, Turan S, Gica S, Bakay H, Pogarell O, Tarhan KN, Metin B. P300 parameters in major depressive disorder: A systematic review and meta-analysis. World J Biol Psychiatry. 2024 Apr;25(4):255-266. doi: 10.1080/15622975.2024.2321554. Epub 2024 May 1.

  PMID: 38493361 BACKGROUND

• Arikan MK, Ilhan R. Gamma-band qEEG biomarkers as trait indicators in depression. J Affect Disord. 2026 Jan 15;393(Pt A):120287. doi: 10.1016/j.jad.2025.120287. Epub 2025 Sep 11.

  PMID: 40945766 BACKGROUND

• Arikan MK, Ilhan R. State-Dependent qEEG Biomarkers in Depression. Clin EEG Neurosci. 2026 Jan;57(1):17-32. doi: 10.1177/15500594251384430. Epub 2025 Oct 7.

  PMID: 41055949 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be retained for DNA, RNA, microRNA extraction

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Selective Serotonin Reuptake Inhibitors; Paroxetine; Fluoxetine; Sertraline; Escitalopram; Duloxetine Hydrochloride; Venlafaxine Hydrochloride; Antidepressive Agents, Second-Generation; Bupropion; Mirtazapine; Trazodone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Antidepressive Agents; Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Propiophenones; Ketones; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Piperazines; Pyridones; Pyridines

Study Officials

• Mehmet Kemal Arıkan, Prof.

  Kemal Arikan Psychiatry Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Kemal Arıkan, Prof.

CONTACT

+905325555005; mkarikan46@gmail.com

Reyhan Ilhan, MSc.

CONTACT

05378586677; psy.reyhan.ilhan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available 12 months after publication of the primary study results and will remain available for at least 5 years thereafter. Supporting documents (protocol, Statistical Analysis Plan, Informed Consent Form, analytical code) will be released at the same time as the de-identified IPD. Long-term archiving beyond 5 years will be maintained depending on repository policies.
• Access Criteria: Access will be provided to qualified researchers for scientifically sound proposals. Requests must include a study protocol, research objectives, and ethics approval from the requester's institution. All requests will be reviewed by an independent data access committee. Approved researchers must sign a Data Use Agreement. Access will be provided through a secure repository, and only de-identified data will be shared. Contact for requests: mkarikan46@gmail.com

Locations

TU (1)