Overview
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.
Description
Peripartum depression is depression that occurs during pregnancy or within the first year after childbirth. It can affect mood, energy, sleep, daily functioning, relationships, and the ability to enjoy pregnancy or early parenthood. Treatment options during this period may be limited because some people prefer to avoid medication, have concerns about medication during pregnancy or breastfeeding, or do not improve sufficiently with their current treatment.
This clinical trial is investigating repetitive transcranial magnetic stimulation (rTMS) as a possible non-medication treatment for peripartum depression. rTMS is a non-invasive treatment in which a coil placed on the scalp delivers short magnetic pulses to a brain area involved in mood regulation. It does not involve surgery, medication, or anaesthesia. rTMS is already used to treat depression in adults; however, more research is needed to understand its effects specifically during pregnancy and after childbirth.
The study will include up to 60 women aged 18 years or older who are pregnant or up to 12 months after giving birth and have clinically relevant depressive symptoms. Before joining the study, interested individuals will receive written study information and have an opportunity to ask questions. Participation begins only after written informed consent has been provided.
At the baseline visit, the study team will review medical, psychiatric, and obstetric history and confirm eligibility. Participants will complete questionnaires about depressive symptoms, wellbeing, quality of life, social support, treatment expectations, and related topics. EEG and ECG recordings will be performed before treatment. Small hair and sputum samples will also be collected to explore stress-related and other hormone levels. These samples will not be used for genetic testing.
Eligible participants will be assigned by chance, in a 1:1 ratio, to receive either active rTMS or sham rTMS. Sham rTMS uses a special coil designed to produce similar sounds and scalp sensations without delivering effective stimulation to the brain. During the main study phase, participants and the clinicians assessing depressive symptoms will not know which treatment has been assigned. This design allows researchers to compare the effects of active rTMS and sham treatment fairly.
Participants will usually receive two sessions per day on five days per week. To accommodate childcare, breastfeeding, fatigue, medical appointments, and other individual needs, the schedule can be adjusted. Participants may receive between one and four sessions per day, with at least 30 minutes between sessions, and must attend at least three sessions per week. Treatment may therefore be completed over approximately 1.5 to 10 weeks. Each visit lasts around 30 minutes, including preparation, treatment, and a safety check. Infants may be brought to treatment appointments when this can be done safely.
The main aim is to determine whether active rTMS reduces depressive symptoms more than sham rTMS from the start to the end of treatment. The study will also assess changes in self-reported mood, quality of life, social support, and other aspects of wellbeing. EEG and ECG recordings will be repeated after treatment. Participants will be contacted by telephone one month after treatment to assess whether any change in depressive symptoms continues. One year after treatment, participants will be invited to complete a short questionnaire about their child's development.
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 potential risk. To reduce risks, individuals with epilepsy, certain metal or electronic implants, or medical or obstetric conditions that could make participation unsafe will not be included. Safety and any side effects will be assessed and documented before or during every treatment session.
Participation is voluntary. Participants may pause or withdraw from the study at any time without affecting their present or future medical care. Personal information will be coded and handled confidentially. Participants assigned to sham rTMS will be offered the option to receive active rTMS after they have completed the blinded study phase. The findings may help determine whether rTMS could become a useful non-medication treatment option for people with peripartum depression.
Eligibility
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.
