| NCT ID | NCT07269964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | MDD |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-08-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-10-01 with a primary completion date of 2026-08-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary purpuse of this pilot study is to find out whether a home-based transcranial direct current stimulation (tDCS) program is feasible and well tolerated as maintenance therapy and whether there are early signs that it helps maintain the clinical clinical benefits achieved during successful acute inpatient treatment. Participant population: Adults (18+) with depressive disorder who had already improved/stabilized after acute treatment at our clinic (esketamine, repetitive transcranial magnetic stimulation , or electroconvulsive therapy). Main questions: Feasibility: Do participants reliably complete the home program and stay in the study? Preliminary effectiveness: Do improvements of depressive symptoms hold up over the 4-week treatment and 2-week follow-up (based on self-report and clinician-rated scales)? Participants receive standardized instruction from trained staff and a portable tDCS device (with cap and small sponge electrodes) and complete 20 home sessions over 4 weeks (5 per week), each 30 minutes at a very low current (2 mA); the device gently ramps current up/down for comfort. During treatment, participants use a smartphone app with step-by-step guidance and reminders; sessions are automatically logged. They will also fill out short weekly self-rating questionnaires and join brief phone check-ins every 2 weeks. Where: Department and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich Safety \& data privacy: The device monitors electrode contact and pauses automatically if contact is poor. Typical sensations can include mild tingling or redness. The app stores anonymized session data so the care team can track progress; no personal data are exchanged between the app and the stimulator, and access is via a secure clinical portal.
Eligibility Criteria
Inclusion Criteria: * Adults (≥18 years). * Diagnosis according to ICD-10: recurrent depressive disorder, severe depressive disorder, schizoaffective disorder (depressive episode) or bipolar affective disorder (depressive episode). * Clear indication for maintenance therapy after successful acute treatment (esketamine, rTMS, or ECT) with remission/improvement of symptoms. * Capacity to provide informed consent, confirmed in a physician-led consent discussion. Exclusion Criteria: * Currently in the acute treatment phase of an affective disorder and non-response to previous treatments. * Currently clinically relevant Axis II disorders. * Suicidal risk, including suicidal ideation. * Contraindications for tDCS: e.g., skin disease at electrode sites, cochlear implants. * Neurological, somatic, or psychiatric comorbidities that could compromise validity or safety.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07269964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MDD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07269964 currently recruiting?
Yes, NCT07269964 is actively recruiting participants. Contact the research team at ulrike.vogelmann@mri.tum.de for enrollment information.
Where is the NCT07269964 trial being conducted?
This trial is being conducted at München, Germany, München, Germany.
Who is sponsoring the NCT07269964 clinical trial?
NCT07269964 is sponsored by Technical University of Munich. The trial plans to enroll 30 participants.