MDDNCT07889739
Sensation Seeking and TMS Response in TRD
An observational study of MDD and Severe Depression, run by Technical University of Munich at 1 site in Germany.
Trial summary
his real-world observational study examines whether sensation-seeking personality traits influence the clinical response to transcranial magnetic stimulation (TMS) in patients with treatment-resistant depression (TRD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MDD, Severe Depression, Major Depressive Episode
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2024to 31 Jan 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adult patients experiencing a current depressive episode related to Major Depressive Disorder (MDD), Bipolar Disorder (Type I or II), or Schizoaffective Disorder who meet clinical criteria for Treatment-Resistant Depression (TRD). All participants receive transcranial magnetic stimulation (TMS) as part of routine clinical care in a specialized neuromodulation program. Participants are consecutively recruited during their standard TMS treatment. The study collects self-report and clinician-rated data, including the Sensation Seeking Scale (SSS) and Montgomery-Åsberg Depression Rating Scale (MADRS), to examine whether sensation-seeking traits are associated with symptom improvement. This population reflects the heterogeneous, real-world clinical cohort typically referred for TMS, including unipolar and bipolar depression, as well as schizoaffective disorder in a depressive phase. Estimated enrollment: 60-100 participants, depending on recruitment flow and data comp
Who may be able to join
- Adults (≥18 years).
- Diagnosis according to ICD-10: recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode) or bipolar affective disorder (depressive episode).
- Treatment-Resistant Depression (TRD): inadequate response to ≥2 adequate antidepressant trials in the current episode (per clinician judgment or ATHF if available).
- Baseline assessments available: MADRS within ≤7 days before first TMS session and baseline Sensation Seeking Scale (SSS) prior to or at treatment initiation.
- Capacity to provide informed consent and ability to complete study questionnaires in the site language.
Who cannot join
- Contraindications to TMS (per device labeling/clinical standards): any ferromagnetic or electronic intracranial/cranial implants, cochlear implant, deep brain stimulator, medication pump near coil, skull defect, or other conditions deemed unsafe by the treating clinician.
- History of seizure/epilepsy (except single, clearly provoked event), current epileptiform disorder, or significant neurological disease lowering seizure threshold (e.g., recent stroke, brain tumor, active TBI with persistent sequelae, active CNS infection).
- Moderate-to-severe substance use disorder within the past 3 months (excluding nicotine/caffeine), per clinician assessment.
- Imminent suicide risk requiring a higher level of care (e.g., active plan/intent) at screening.
- Concurrent acute ECT or investigational device/drug during the TMS acute course (participation allowed if such treatments are not initiated during the observation window).
- Any condition that, in the judgment of the treating clinician or PI, would preclude safe TMS delivery or reliable outcome measurement (e.g., severe cognitive impairment preventing valid MADRS/SSS completion).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy,
München, Bavaria, 81675
Ulrike Vogelmann, Dr.med, 08941406882 ext. +49, ulrike.vogelmann@mri.tum.de
Joan Koti, MD, 017635737540 ext. +49, joan.koti@mri.tum.de
About this study
Official title: Impact of Sensation Seeking on Clinical Outcomes of Transcranial Magnetic Stimulation (TMS) in Patients With Treatment-Resistant Depression (TRD)
his real-world observational study examines whether sensation-seeking personality traits influence the clinical response to transcranial magnetic stimulation (TMS) in patients with treatment-resistant depression (TRD). Participants will complete a validated sensation seeking scale prior to TMS treatment, and depressive symptoms will be assessed using standardized clinical scales during and after the TMS course.
Read the detailed description
his study aims to explore the relationship between sensation seeking traits and clinical outcomes following TMS therapy in adults with treatment-resistant depression (TRD). Using a naturalistic, real-world treatment setting, patients undergoing standard TMS therapy will complete a validated sensation seeking questionnaire (e.g., Zuckerman Sensation Seeking Scale or similar) prior to treatment initiation. Depression severity will be measured at baseline, mid-treatment, and post-treatment using established scales (e.g., HAM-D, MADRS, or PHQ-9). The study will analyze whether sensation seeking predicts treatment response or remission rates, contributing to a better understanding of psychological moderators of TMS effectiveness.
- Conditions
- MDD, Severe Depression, Major Depressive Episode
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- Transcranial Magnetic Stimulation, TMS, Treatment-Resistant Depression, Sensation Seeking; Personality Traits, Depression, Real-world Study, Observational Research
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Other
Patients with treatment-resistant depression will receive standard clinical TMS therapy according to usual clinical protocols. The study will observe treatment outcomes and assess the association with individual sensation seeking traits. No experimental intervention or randomization is applied.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores and Baseline Sensation Seeking Scale (SSS) Total Score
The primary analysis will test the correlation between change in depressive symptom severity (ΔMADRS = baseline MADRS - end-of-treatment MADRS) and the baseline Sensation Seeking Scale total score. Pearson's or Spearman's correlation coefficient (r/ρ) will be calculated, with 95% confidence intervals.
Measured: Baseline (within 7 days before first TMS session) to end of acute TMS course (approximately 4-6 weeks)
Secondary outcomes (1)
Association Between Change in MADRS and SSS Total Score (Adjusted Model)
Multivariable linear regression of ΔMADRS on baseline SSS total, adjusting for age, sex, baseline MADRS, treatment parameters, and TRD burden.
Measured: Baseline to end of acute TMS (4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start2 May 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies 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
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Vogelmann, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889739
- Sponsor's protocol ID
- RWNM_rTMS_SS
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymised study outcomes will be shared, including questionnaire, physiological, and device data.