NCT Number: NCT07774559
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 opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Psychiatric University Hospital, Ambulatorium Quadro, Zurich, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: High-frequency rTMS, 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.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
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
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II) at baseline and at the end of the assigned treatment phase. The secondary outcome is the change in BDI-II score from baseline to the end of treatment, compared between the active-rTMS and sham-rTMS groups. The Beck Depression Inventory, Second Edition (BDI-II) measures the severity of depressive symptoms. Possible scores range from 0 to 63, with higher scores indicating more severe depression.
Time frame: at baseline, weekly during treatment, and end of treatment (up to 10 Weeks)
Peripartum depressive symptoms will be assessed weekly using the Edinburgh Postnatal Depression Scale (EPDS). Change in EPDS score from baseline to the end of treatment will be compared between treatment groups. The Edinburgh Postnatal Depression Scale (EPDS) measures the severity of depressive symptoms in the perinatal period. Possible scores range from 0 to 30, with higher scores indicating more severe depressive symptoms.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Overall clinical status will be assessed using the Clinical Global Impression (CGI) scale at baseline and at the end of treatment. Change in CGI score will be compared between treatment groups. The Clinical Global Impression - Severity scale (CGI-S) measures the clinician's global rating of illness severity. Possible scores range from 1 to 7, with higher scores indicating greater illness severity.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Mental health-related quality of life will be assessed using the Mental Health Quality of Life (MHQoL) questionnaire. Change in MHQoL score from baseline to the end of treatment will be compared between treatment groups. The Mental Health Quality of Life Questionnaire, 7-dimension index (MHQoL-7D), measures mental health-related quality of life across seven domains. Possible scores range from 0 to 21, with higher scores indicating better mental health-related quality of life.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Perceived social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). Change in MSPSS score from baseline to the end of treatment will be compared between treatment groups. The Multidimensional Scale of Perceived Social Support (MSPSS) measures perceived social support from family, friends, and significant others. Possible scores range from 12 to 84, with higher scores indicating greater perceived social support.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Suicidal thoughts and behaviours will be assessed using the Suicidal Behaviors Questionnaire-Revised (SBQ-R). Change in SBQ-R score from baseline to the end of treatment will be compared between treatment groups. The Suicidal Behaviors Questionnaire-Revised (SBQ-R) measures risk of suicidal behavior. Possible scores range from 3 to 18, with higher scores indicating greater suicide risk.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Dietary habits will be assessed using Food Frequency Items (FFI). Change in FFI score from baseline to the end of treatment will be compared between treatment groups. The Food Frequency Items (FFI) is a questionnaire to record participants' dietary intake patterns, results are reported descriptively by food category.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES). Change in GSES score from baseline to the end of treatment will be compared between treatment groups. The General Self-Efficacy Scale (GSES) measures a person's belief in their own ability to cope with challenging situations. Possible scores range from 10 to 40, with higher scores indicating greater self-efficacy.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
Treatment expectations will be assessed using the Treatment Expectation Questionnaire (TEX-Q). TEX-Q scores will be assessed in relation to the assigned treatment and compared between treatment groups. The Treatment Expectation Questionnaire (TEX-Q) assesses patients' expectations regarding the treatment's anticipated benefits, adverse effects, and impact on daily functioning across several subscales, each rated on an 11-point scale (0-10). Because the subscales are interpreted separately and higher scores do not indicate a uniformly better or worse outcome across all of them, subscale scores are reported individually rather than as a single combined range.
Time frame: End of treatment (up to 10 weeks)
At the end of treatment, participants will indicate whether they believe they received active or sham rTMS and how confident they are in that assessment. The Blinding Credibility Questionnaire (BCQ) asks participants to indicate whether they believe they received active or sham rTMS and to rate their confidence in that belief. It does not produce a single summed score with a minimum, maximum, or direction; results are reported as the proportion of participants correctly/incorrectly guessing their treatment allocation, together with their confidence ratings.
Time frame: at baseline, at the end of treatment and 1 month after completion of the rTMS treatment
Depressive symptom severity will be assessed using the MADRS during a telephone follow-up. Change in MADRS score from baseline to one month after treatment will be compared between treatment 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
Time frame: at baseline and at the end of treatment (up to 10 weeks)
EEG recordings will be obtained before and after treatment. Changes in predefined EEG measures will be compared between treatment groups.
EEG recordings are analyzed for spectral power in five standard frequency bands (delta, theta, alpha, beta, and gamma, the latter further divided into two sub-bands), together with Alpha Peak Frequency, Frontal Alpha Asymmetry, and EEG-vigilance regulation. The baseline EEG recording additionally serves a safety-screening purpose, identifying epileptiform potentials to to exclude participants with evidence of clinical or subclinical epilepsy prior to initiating rTMS, per the study's exclusion criteria.
Time frame: at baseline and at the end of treatment (up to 10 weeks)
ECG recordings will be obtained before and after treatment. Changes in predefined ECG measures will be compared between treatment groups. ECG recordings are analyzed via heart-rate variability derived from the R-R interval series, parameters include heart rate, heart-rate regulation slope, absolute HRV power, low-frequency and high-frequency spectral power, and the relative sympathetic activity index.
Time frame: at baseline
Hair and sputum samples will be collected to assess stress-related and other hormone levels. Samples will be analysed according to the study laboratory procedures.
Time frame: 12 months after completion of the rTMS treatment
Participants will complete the Parents' Evaluation of Developmental Status (PEDS) questionnaire to identify possible developmental concerns in their child. The Parents' Evaluation of Developmental Status (PEDS) Response Form elicits parents' concerns about their child's development, behavior, and mental health across several domains (e.g., language, motor skills, social-emotional functioning, self-help). It does not produce a single summed score with a minimum, maximum, or direction.
Time frame: From randomization through end of treatment, assessed at each of the 30 rTMS sessions (up to 10 Weeks)
Adverse events, including rTMS-related symptoms such as headache, scalp discomfort, dizziness, fatigue, or facial muscle twitching, will be assessed and documented at every treatment session. Serious adverse events will be recorded and evaluated according to study safety procedures.
Contact information is provided by the study sponsor or research team.
Barbora Provaznikova, Dr. med.
CONTACT
Sara Romer
CONTACT
Psychiatric University Hospital, Zurich
Other
Acronym: PPD and rTMS
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