NCT07853989

Brief Summary

This prospective observational study aims to evaluate changes in psychological defense mechanisms in patients with non-psychotic major depressive disorder (MDD) undergoing repetitive Transcranial Magnetic Stimulation (rTMS) therapy. The study investigates whether rTMS induces a shift from immature to more mature defense mechanisms and assesses how these changes relate to improvements in depressive symptom severity, anxiety levels, and overall functionality at baseline, 1-month, and 3-month follow-ups.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jul 2027

First Submitted

Initial submission to the registry

September 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Major Depressive Disorder (MDD)

Keywords

TMSTranscranial Magnetic StimulationDefense Mechanismsdepressionfunctionality

Outcome Measures

Primary Outcomes (2)

  • Change in Defense Mechanisms (Defense Style Questionnaire - DSQ)

    Evaluates shifts in mature, neurotic, and immature psychological defense mechanism styles in patients with major depressive disorder following TMS treatment.

    Baseline, 1 month, and 3 months

  • Change in Disability and Functionality (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)

    Evaluates level of functional disability across six domains (understanding/communicating, mobility, self-care, getting along, life activities, participation).

    Baseline, 1 month, and 3 months

Secondary Outcomes (3)

  • Change in Anxiety Symptom Severity (Hamilton Anxiety Rating Scale - HAM-A)

    Baseline, 1 month and 3 months

  • Change in Depressive Symptom Severity (Hamilton Depression Rating Scale - HAM-D)

    Baseline, 1 month, and 3 months

  • Change in Clinical Global Impression (CGI)

    Baseline, 1 month, and 3 months

Study Arms (1)

TMS Treatment Group

EXPERIMENTAL

Patients diagnosed with major depressive disorder receiving Transcranial Magnetic Stimulation therapy.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

TMS protocol administered to patients with major depressive disorder.

TMS Treatment Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • Diagnosis of major depressive disorder without psychotic features according to DSM-5 criteria
  • Confirmation of diagnosis via SCID-5
  • Major depressive disorder as the primary reason for admission
  • Willingness to participate and signing the written informed consent form

You may not qualify if:

  • Presence of contraindications for TMS (e.g., metallic implants)
  • Known active psychotic symptoms
  • History of TMS treatment in the past 3 months
  • Presence of known organic brain syndrome, neurological, or major systemic medical conditions
  • Presence of known intellectual disability or significant cognitive impairment
  • Active substance or alcohol use disorder
  • Illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdağ Namik Kemal University Faculty of Medicine, Department of Psychiatry

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Kardelen Erdoğan, MD

CONTACT

+90 543 691 87 52kardelenerdogan@nku.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Clinical outcomes and psychological scales are evaluated by an independent researcher who is blinded to the treatment process.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)