PPD and rTMSNCT07774559

Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression

StatusRecruiting

PhaseNot applicable

SponsorPsychiatric University Hospital, Zurich

Primary completionAug 31, 2030 (estimated)

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 2, 2026 Recruitment opened Show 5 more changesShow less
- Eligibility criteria expanded, about 18 words
- Start date changed from estimate of Sep 2026 to Oct 27, 2026
- Secondary endpoints: details revised at 15 of 15 entries
- Site details revised at 2 of 2 sites
- Publications: details revised at 2 of 2 entries
Aug 17, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Change in depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)

Timeframe: at baseline and at the end of treatment (up to 10 weeks)

Secondary (15)

Change in Beck Depression Inventory-II (BDI-II) score

Change in Edinburgh Postnatal Depression Scale (EPDS) score

Change in Clinical Global Impression (CGI) score

Change in Mental Health Quality of Life (MHQoL) score

Change in Multidimensional Scale of Perceived Social Support (MSPSS) score

Show 10 moreShow less

Change in Suicidal Behaviors Questionnaire-Revised (SBQ-R) score

Change in Food Frequency Items (FFI) score

Change in General Self-Efficacy Scale (GSES) score

Change in Treatment Expectation Questionnaire (TEX-Q) score

Blinding credibility assessed by the Blinding Credibility Questionnaire (BCQ)

Change in MADRS score at 1-month follow-up

Change in electroencephalography (EEG) measures

Change in electrocardiography (ECG) measures

Hormone levels in hair and sputum samples

Child development assessed by Parents' Evaluation of Developmental Status (PEDS)

Arms and interventions

Active rTMSExperimental

Participants receive 30 sessions of active high-frequency rTMS targeting the left dorsolateral prefrontal cortex.

Sham rTMSSham comparator

Participants receive 30 sessions of sham rTMS using a validated sham coil that reproduces the sound and scalp sensations of active rTMS without effective brain stimulation.

Devices: Repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation

Sites

2 sites in 1 country

About this trial

The goal of this clinical trial is to learn whether repetitive transcranial magnetic stimulation (rTMS) can reduce depressive symptoms in women who are pregnant or up to 12 months after childbirth and have peripartum depression. rTMS is a non-invasive treatment in which a device placed on the scalp delivers gentle magnetic pulses to a brain area involved in mood regulation. It does not involve medication or anaesthesia. The main questions this study aims to answer are: * Does active rTMS reduce depressive symptoms more than sham rTMS? * What side effects occur during treatment, and how well is rTMS tolerated? * Are improvements in depressive symptoms still present one month after treatment? Researchers will compare active rTMS with sham rTMS, a treatment designed to feel and sound similar but not to provide effective brain stimulation. Neither participants nor the clinicians assessing depressive symptoms will know which treatment was assigned during the main study phase. Up to 60 women aged 18 years or older who are pregnant or up to 12 months after childbirth and have clinically relevant depressive symptoms may take part. Participants will: * Attend a screening and baseline visit, including questionnaires, EEG and ECG recordings, and collection of small hair and sputum samples to study stress-related hormone levels * Be assigned by chance to receive either active rTMS or sham rTMS * Attend 30 treatment sessions, scheduled flexibly over approximately 1.5 to 10 weeks to accommodate childcare, breastfeeding, fatigue, and medical appointments * Complete questionnaires about mood, wellbeing, quality of life, social support, and treatment expectations before and after treatment * Have safety and side effects checked before each treatment session * Complete a telephone follow-up assessment one month after treatment * Be asked to complete a short questionnaire about their child's development one year after treatment Each treatment visit lasts about 30 minutes, including preparation, treatment, and a short safety check. Infants may be brought to treatment visits when this can be done safely. rTMS is generally well tolerated. Possible temporary side effects include headache, scalp discomfort, facial muscle twitching during stimulation, dizziness, or tiredness. A seizure is a very rare but serious possible risk; therefore, people with epilepsy, certain implants, or other relevant risk factors cannot take part. Participation is voluntary. Participants can pause or stop participation at any time without affecting their usual care. Personal data will be coded and handled confidentially. Women assigned to sham treatment will be offered active rTMS after the blinded study phase, if they wish. The results may help clarify whether rTMS is an effective non-medication treatment option for peripartum depression.

Trial details

Enrollment: 60 participants (estimated)
Started: Oct 27, 2026
Study completion: Aug 31, 2030 (estimated)
Eligibility: 18 and older, female only, no healthy volunteers
Design: Interventional, randomized, double blind, treatment
Oversight: No data monitoring committee
Conditions: Depression, Postpartum, Depression During Pregnancy, Postpartum Depression (PPD), Peripartum Depression
First posted: Aug 19, 2026
Registry updated: Nov 3, 2026
Last verified: Nov 2026

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