Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression

Summary

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.

Conditions

• Depression During Pregnancy
• Postpartum Depression (PPD)
• Peripartum Depression

Interventions

DEVICE

Repetitive transcranial magnetic stimulation

Active repetitive transcranial magnetic stimulation (rTMS) is delivered to the left dorsolateral prefrontal cortex using a CE-marked MagVenture MagPro system with a figure-of-eight coil. Stimulation is delivered at 10 Hz and at 80-120% of the individual resting motor threshold, with 1,200 pulses per session. Participants are scheduled to receive 30 sessions.

DEVICE

Sham repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation (sham rTMS) is delivered using a validated sham coil. The sham procedure matches active rTMS in coil positioning, treatment schedule, device displays, sounds, and scalp sensations, but does not provide effective stimulation to the brain. Participants are scheduled to receive 30 sham sessions using the same flexible scheduling as the active-rTMS group.

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich

  lead OTHER

Principal Investigators

• Sebastian Olbrich · Psychiatric University Hospital, Zurich

• Barbora Provaznikova · Psychiatric University Hospital, Zurich

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2030-08-31

Completion

2030-08-31

Countries

• Switzerland

Study Locations