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Sponsor: Psychiatric University Hospital, Zurich
Conditions: Depression During Pregnancy, Postpartum Depression (PPD), Peripartum Depression
Interventions: Repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
Countries: Switzerland
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.
Sex: FEMALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
- Zurich, Switzerland
- Zurich, Switzerland