- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07853989
Effect of TMS Treatment on Defense Mechanisms and Functionality in Patients With Depression
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Kardelen Erdoğan, MD
- Telefoonnummer: +90 543 691 87 52
- E-mail: kardelenerdogan@nku.edu.tr
Studie Locaties
-
-
-
Tekirdağ, Turkije (Türkiye)
- Tekirdağ Namik Kemal University Faculty of Medicine, Department of Psychiatry
-
Contact:
- kardeeln erdoğan, MD
- Telefoonnummer: +90 543 691 87 52
- E-mail: kardelenerdogan@nku.edu.tr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
|---|
|
TMS Treatment Group
Patients diagnosed with major depressive disorder receiving Transcranial Magnetic Stimulation therapy. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Defense Mechanisms (Defense Style Questionnaire - DSQ)
Tijdsspanne: 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. |
Baseline, 1 month, and 3 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Anxiety Symptom Severity (Hamilton Anxiety Rating Scale - HAM-A)
Tijdsspanne: Baseline, 1 month and 3 months
|
Assesses psychic and somatic anxiety symptom severity. |
Baseline, 1 month and 3 months
|
|
Change in Depressive Symptom Severity (Hamilton Depression Rating Scale - HAM-D)
Tijdsspanne: Baseline, 1 month, and 3 months
|
Assesses the severity of depressive symptoms |
Baseline, 1 month, and 3 months
|
|
Change in Clinical Global Impression (CGI)
Tijdsspanne: Baseline, 1 month, and 3 months
|
Measures overall illness severity and clinical improvement. |
Baseline, 1 month, and 3 months
|
|
Change in Disability and Functionality (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)
Tijdsspanne: Baseline, 1 month, and 3 months
|
Evaluates level of functional disability across six domains (understanding/communicating, mobility, self-care, getting along, life activities, participation). |
Baseline, 1 month, and 3 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026.197.07.01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .