Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression

ConditionsDepression During Pregnancy Postpartum Depression (PPD)Peripartum Depression

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorPsychiatric University Hospital, Zurich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Active rTMSExperimental treatment 1 intervention

Group B: Sham rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Secondary outcomes

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

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

Change in Edinburgh Postnatal Depression Scale (EPDS) score

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

Change in Clinical Global Impression (CGI) score

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)

Change in Mental Health Quality of Life (MHQoL) score

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)

Other outcomes

Incidence and severity of adverse events

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Psychiatric University Hospital, Zurich

Lead sponsor

Source ClinicalTrials.gov

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