Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression

NCT07774559 | Not Yet Recruiting

• 1 other identifier: 2025-02580
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Peripartal depression; Postpartal depression; Antenatal depression; Repetitive transcranial magnetic stimulation; Transcranial magnetic stimulation; rTMS

Outcome Measures

Primary Outcomes (1)

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

  Depressive symptom severity will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline and at the end of the assigned treatment phase. The primary outcome is the change in MADRS score from baseline to the end of treatment, compared between the active-rTMS and sham-rTMS groups. The Montgomery-Åsberg Depression Rating Scale (MADRS) measures the severity of depressive symptoms. Possible scores range from 0 to 60, with higher scores indicating more severe depression

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

Secondary Outcomes (15)

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

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

• Change in Edinburgh Postnatal Depression Scale (EPDS) score

  at baseline, weekly during treatment, and end of treatment (up to 10 Weeks)

• Change in Clinical Global Impression (CGI) score

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

• Change in Mental Health Quality of Life (MHQoL) score

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

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

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

Other Outcomes (1)

• Incidence and severity of adverse events

  From randomization through end of treatment, assessed at each of the 30 rTMS sessions (up to 10 Weeks)

Study Arms (2)

Active rTMS

EXPERIMENTAL

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

Device: Repetitive transcranial magnetic stimulation

Sham rTMS

SHAM 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.

Device: Sham repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

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.

Also known as: High-frequency rTMS, transcranial magnetic stimulation

Active rTMS

Sham repetitive transcranial magnetic stimulation DEVICE

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.

Sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older
• Currently pregnant or up to 12 months after childbirth at screening
• Current depressive episode or clinically significant depressive symptoms consistent with peripartum depression, confirmed by clinical interview according to ICD-10 criteria
• MADRS score of at least 7 at screening
• Able to understand German or English
• Able to provide written informed consent
• Willing and able to attend study visits and complete rTMS procedures, EEG and ECG recordings, hair and sputum sampling, and study questionnaires
• Stable antidepressant and/or psychotherapy treatment, or no current antidepressant medication and/or psychotherapy; participants should agree to maintain treatment stability during the study where clinically feasible
• Previous rTMS treatment for depression is permitted

You may not qualify if:

• Current or past seizure disorder, or previous rTMS-induced seizure
• Primary psychotic disorder
• Acute suicidality requiring a higher level of care
• Contraindications to rTMS, including intracranial metallic implants; implanted neurostimulators; cochlear implants; vagus nerve stimulators; ocular implants; implanted cardiac electrodes or pacemakers; aneurysm coils or clips; ventriculo-peritoneal shunts; or other ferromagnetic or electronic implants in the head or neck
• Clinically significant head injury within the previous 12 months or with relevant residual symptoms
• Unstable or severe medical or obstetric complications that could make participation unsafe, such as preeclampsia or imminent preterm labour requiring intensive management
• Severe substance use disorder that could interfere with safety or study assessments
• Inability to follow study procedures, for example because of cognitive impairment
• Frequent severe migraine, including chronic migraine with status migrainosus, if high-frequency rTMS is considered likely to worsen symptoms, unless the investigator and treating physician determine that participation is safe.

Sponsors & Collaborators

• Psychiatric University Hospital, Zurich: lead

Study Sites (2)

University Hospital of Psychiatry Zurich (PUK Zürich), Main Campus

Zurich, 8032, Switzerland

Location

Psychiatric University Hospital, Ambulatorium Quadro

Zurich, 8050, Switzerland

Location

Related Publications (2)

• Myczkowski ML, Dias AM, Luvisotto T, Arnaut D, Bellini BB, Mansur CG, Renno J, Tortella G, Ribeiro PL, Marcolin MA. Effects of repetitive transcranial magnetic stimulation on clinical, social, and cognitive performance in postpartum depression. Neuropsychiatr Dis Treat. 2012;8:491-500. doi: 10.2147/NDT.S33851. Epub 2012 Oct 25.

  PMID: 23118543 BACKGROUND

• Kim DR, Wang E, McGeehan B, Snell J, Ewing G, Iannelli C, O'Reardon JP, Sammel MD, Epperson CN. Randomized controlled trial of transcranial magnetic stimulation in pregnant women with major depressive disorder. Brain Stimul. 2019 Jan-Feb;12(1):96-102. doi: 10.1016/j.brs.2018.09.005. Epub 2018 Sep 14.

  PMID: 30249416 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sebastian Olbrich

  Psychiatric University Hospital, Zurich

  STUDY DIRECTOR

• Barbora Provaznikova

  Psychiatric University Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbora Provaznikova, Dr. med.

CONTACT

+41 58 384 35 12; barbora.provaznikova@uzh.ch

Sara Romer

CONTACT

+41 58 384 26 02; sara.romer@bli.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, sham-controlled, parallel-group study. Participants are assigned in a 1:1 ratio to receive either active rTMS or sham rTMS for 30 treatment sessions. Participants and outcome assessors remain blinded to treatment allocation during the main treatment phase. After completion of the end-of-treatment assessments, participants assigned to sham rTMS may choose to receive active rTMS outside the formal blinded study phase.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

CH (2)