Major Depressive Disorder (MDD)NCT07853989
Effect of TMS Treatment on Defense Mechanisms and Functionality in Patients With Depression
An observational study of Major Depressive Disorder (MDD), run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-65 years with non-psychotic major depressive disorder (MDD) who are evaluated for suitability for transcranial magnetic stimulation (TMS) treatment at the Psychiatry Clinic/TMS Unit of Tekirdağ Namık Kemal University Hospital. The diagnosis of MDD will be confirmed using the Structured Clinical Interview for DSM Disorders (SCID). Approximately 50 participants who meet the eligibility criteria and provide written informed consent will be included.
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of major depressive disorder without psychotic features according to DSM-5 criteria
- Confirmation of diagnosis via SCID
- Major depressive disorder as the primary reason for admission
- Willingness to participate and signing the written informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tekirdağ Namik Kemal University Faculty of Medicine, Department of Psychiatry
Tekirdağ
kardeeln erdoğan, MD, +90 543 691 87 52, kardelenerdogan@nku.edu.tr
About this study
Official title: The Effect of Transcranial Magnetic Stimulation (TMS) Treatment on Defense Mechanisms and Functionality in Patients With Depression
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.
Read the detailed description
Major depressive disorder (MDD) significantly impacts mood, cognitive function, and psychological defense structures. While repetitive Transcranial Magnetic Stimulation (rTMS) is an established non-invasive neuromodulation therapy for depression, its influence on psychodynamic constructs such as defense mechanisms remains insufficiently explored.
This single-center prospective study will enroll 50 adult participants (aged 18-65) diagnosed with non-psychotic MDD according to DSM-5 criteria (confirmed via SCID-5). Participants will receive rTMS treatment as part of their standard clinical care. Clinical assessments will be conducted by a blinded researcher at three time points: baseline (pre-treatment), 1 month, and 3 months post-baseline.
Primary outcomes will measure shifts in defense mechanism styles (mature, neurotic, immature) using the Defense Style Questionnaire (DSQ). Secondary outcomes will assess depressive symptom severity (Hamilton Depression Rating Scale - HAM-D), anxiety levels (Hamilton Anxiety Rating Scale - HAM-A), clinical severity and improvement (Clinical Global Impression Scale - CGI), and functional impairment (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0).
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- TMS, Transcranial Magnetic Stimulation, Defense Mechanisms, depression, functionality
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TMS Treatment Group | Patients diagnosed with major depressive disorder receiving Transcranial Magnetic Stimulation therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (4)
Change in Anxiety Symptom Severity (Hamilton Anxiety Rating Scale - HAM-A)
Assesses psychic and somatic anxiety symptom severity.
Measured: Baseline, 1 month and 3 months
Change in Depressive Symptom Severity (Hamilton Depression Rating Scale - HAM-D)
Assesses the severity of depressive symptoms
Measured: Baseline, 1 month, and 3 months
Change in Clinical Global Impression (CGI)
Measures overall illness severity and clinical improvement.
Measured: 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).
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen Erdoğan, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853989
- Sponsor's protocol ID
- 2026.197.07.01
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Magnetic Stimulation (TMS) Treatment on Defense Mechanisms and Functionality in Patients With Depression
- ClinicalTrials.gov ID
- NCT07853989
- Acronym / sponsor ID
- 2026.197.07.01
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- TMS, Transcranial Magnetic Stimulation, Defense Mechanisms, depression, functionality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Major depressive disorder (MDD) significantly impacts mood, cognitive function, and psychological defense structures. While repetitive Transcranial Magnetic Stimulation (rTMS) is an established non-invasive neuromodulation therapy for depression, its influence on psychodynamic constructs such as defense mechanisms remains insufficiently explored.
This single-center prospective study will enroll 50 adult participants (aged 18-65) diagnosed with non-psychotic MDD according to DSM-5 criteria (confirmed via SCID-5). Participants will receive rTMS treatment as part of their standard clinical care. Clinical assessments will be conducted by a blinded researcher at three time points: baseline (pre-treatment), 1 month, and 3 months post-baseline.
Primary outcomes will measure shifts in defense mechanism styles (mature, neurotic, immature) using the Defense Style Questionnaire (DSQ). Secondary outcomes will assess depressive symptom severity (Hamilton Depression Rating Scale - HAM-D), anxiety levels (Hamilton Anxiety Rating Scale - HAM-A), clinical severity and improvement (Clinical Global Impression Scale - CGI), and functional impairment (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS Treatment Group | – | –Patients diagnosed with major depressive disorder receiving Transcranial Magnetic Stimulation therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-65 years with non-psychotic major depressive disorder (MDD) who are evaluated for suitability for transcranial magnetic stimulation (TMS) treatment at the Psychiatry Clinic/TMS Unit of Tekirdağ Namık Kemal University Hospital. The diagnosis of MDD will be confirmed using the Structured Clinical Interview for DSM Disorders (SCID). Approximately 50 participants who meet the eligibility criteria and provide written informed consent will be included.
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Diagnosis of major depressive disorder without psychotic features according to DSM-5 criteria
- Confirmation of diagnosis via SCID
- Major depressive disorder as the primary reason for admission
- Willingness to participate and signing the written informed consent form
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Defense Mechanisms (Defense Style Questionnaire - DSQ)
Time frame: Baseline, 1 month, and 3 months
Evaluates shifts in mature, neurotic, and immature psychological defense mechanism styles in patients with major depressive disorder following TMS treatment.
4 secondary outcomes
Change in Anxiety Symptom Severity (Hamilton Anxiety Rating Scale - HAM-A)
Time frame: Baseline, 1 month and 3 months
Change in Depressive Symptom Severity (Hamilton Depression Rating Scale - HAM-D)
Time frame: Baseline, 1 month, and 3 months
Change in Clinical Global Impression (CGI)
Time frame: Baseline, 1 month, and 3 months
Change in Disability and Functionality (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)
Time frame: Baseline, 1 month, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kardelen Erdoğan, MD (+90 543 691 87 52, kardelenerdogan@nku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Defense Mechanisms (Defense Style Questionnaire - DSQ) (time frame: Baseline, 1 month, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.