An interventional study of Transcranial Magnetic Stimulation (TMS) in Perinatal Depression, sponsored by Rana Jawish. Active, not recruiting at 1 site in United States. Open to female participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Rana Jawish · Not applicable, Interventional, and Treatment
This study will evaluate the use of transcranial magnetic stimulation (TMS) to treat depression during pregnancy and the first year after childbirth. TMS is a noninvasive treatment that uses magnetic pulses applied to the scalp to stimulate areas of the brain involved in depression. The main goal of the study is to determine whether TMS treatment is feasible, acceptable, and safe for women with perinatal depression. The study will also collect preliminary information about whether TMS reduces symptoms of depression and whether improvements are maintained after treatment.
Up to 100 women age 22 years and older who have major depression and are either 12 to 28 weeks pregnant or within 12 months after giving birth will participate. All participants will receive TMS; there is no placebo or comparison group. Participants will receive 20 to 36 TMS treatment sessions over approximately 4 to 8 weeks, with up to five sessions per week. Depression and other mental health symptoms, treatment attendance, satisfaction with treatment, and safety will be assessed before, during, and approximately one month after TMS treatment.
The study hypothesis is that TMS will be a feasible and acceptable treatment for women with perinatal depression, as shown by participants completing and adhering to treatment, acceptable treatment satisfaction, and appropriate safety outcomes. The study will also explore whether depressive symptoms improve during TMS treatment and whether improvement is sustained one month after treatment. For women who participate while pregnant, the study team will review maternal and infant medical records approximately six months after delivery to assess pregnancy, delivery, postpartum, and infant health outcomes.
This is a prospective, open-label, single-arm clinical study designed to evaluate the feasibility, acceptability, safety, and preliminary clinical outcomes of transcranial magnetic stimulation (TMS) for the treatment of perinatal depression. The study will examine the use of TMS in women experiencing major depression during pregnancy or within the first year postpartum.
Depression during pregnancy and the postpartum period is associated with significant maternal health risks and adverse pregnancy and infant outcomes. Although effective treatments for depression are available, some women may prefer nonpharmacologic treatment options or may experience inadequate improvement with existing treatments. TMS is a noninvasive brain stimulation treatment cleared by the U.S. Food and Drug Administration (FDA) for major depressive disorder in adults. However, evidence regarding its use during pregnancy and the postpartum period remains limited. Additional research is needed to establish the feasibility, acceptability, safety, and potential clinical benefits of TMS in this population.
The primary objective is to determine whether a course of TMS treatment is feasible and acceptable for women with perinatal depression. Feasibility will be assessed through treatment retention and adherence, including the proportion of participants who complete at least 20 treatment sessions and the proportion who attend at least 80% of scheduled sessions. Acceptability will be evaluated using participant-reported treatment satisfaction. Safety will be assessed through systematic monitoring of adverse events, including maternal and fetal outcomes when applicable, and the completeness of clinical data will also be evaluated.
A secondary objective is to collect preliminary information about the clinical effects of TMS on depressive symptoms. Exploratory analyses will examine changes in depression severity, anxiety, rumination, sleep quality, trauma-related symptoms, daily functioning, and maternal attachment during treatment. The study will also evaluate rates of clinical response and remission and explore whether improvements in depressive symptoms are maintained approximately one month after treatment completion.
Participants will receive an individualized course of TMS using established clinical stimulation parameters targeting the left dorsolateral prefrontal cortex, a brain region involved in mood regulation. Treatment will continue for a minimum of 20 sessions, with additional sessions provided as needed based on clinical response, up to a maximum of 36 sessions. Participants who meet the study's remission criteria after completing at least 20 sessions may transition to follow-up.
Clinical assessments will be conducted before treatment, weekly during treatment, and approximately one month after the final treatment session. Standardized clinician-rated assessments and participant questionnaires will be used to evaluate changes in psychiatric symptoms, functioning, and treatment experience. Maternal safety will be monitored throughout treatment, with additional obstetric monitoring and coordination with prenatal care providers for pregnant participants.
For participants enrolled during pregnancy, maternal and infant medical records will be reviewed approximately six months after delivery. This review will examine maternal mental health, pregnancy and delivery complications, postpartum health, and infant outcomes, including birth characteristics, neonatal complications, and health status through six months of age.
Because this is a single-arm, open-label study without a comparison group, the findings will primarily provide information about the feasibility, acceptability, and safety of delivering TMS during the perinatal period, along with preliminary estimates of changes in depressive symptoms. The results will inform the design of future controlled clinical trials evaluating TMS as a treatment option for perinatal depression.
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 100 is close to the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →This is the only study on the registry with Rana Jawish as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive active transcranial magnetic stimulation (TMS) targeting the left dorsolateral prefrontal cortex (DLPFC) using the NeuroStar TMS system. Treatment will consist of standard repetitive TMS (10 Hz) or intermittent theta burst stimulation (iTBS), delivered at 120% of the individual's resting motor threshold. Participants will receive one treatment session per day, up to five days per week, for a total of 20-36 sessions over approximately 4-8 weeks. Participants who achieve remission after completing at least 20 sessions may end treatment, while those who have not achieved remission may continue treatment for up to 36 sessions. All participants will be monitored for safety and clinical response throughout treatment.
Device: Transcranial Magnetic Stimulation (TMS)
Participants will receive active transcranial magnetic stimulation (TMS) using the NeuroStar TMS system, targeting the left dorsolateral prefrontal cortex (DLPFC). Treatment will use FDA-cleared stimulation parameters for major depressive disorder, including standard repetitive TMS (rTMS) at 10 Hz (3,000 pulses per session) or intermittent theta burst stimulation (iTBS; 600 pulses per session). Stimulation intensity will be set at 80-120% of each participant's resting motor threshold. Participants will receive one session per day, up to five days per week, for a total of 20-36 sessions over 4-8 weeks.
Also known as: Repetitive Transcranial Magnetic Stimulation (rTMS), Intermittent Theta Burst Stimulation (iTBS), NeuroStar TMS
Retention Rate
Proportion of participants who complete at least 20 TMS treatment sessions.
Time frame: 8 weeks post baseline
Treatment Adherence Rate
Proportion of participants who complete at least 80% of their scheduled TMS treatment sessions.
Time frame: 8 weeks post baseline
Client Satisfaction Questionnaire (CSQ-8)
Participant satisfaction with TMS treatment measured using the 8-item Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. A score of 24 or higher is the predefined acceptability threshold.
Time frame: 8 weeks post baseline
Maternal adverse events
Incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) associated with TMS treatment.
Time frame: Throughout treatment (up to 8 weeks), with maternal medical record review 6 months (+/- 15 days) after delivery for participants enrolled during pregnancy
Fetal Adverse Events
Incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) related to the fetus.
Time frame: Throughout treatment (up to 8 weeks post baseline) and up to delivery for participants enrolled during pregnancy
Neonatal adverse events
Incidence, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) related to the infant from birth through 6 months postpartum for participants enrolled during pregnancy
Time frame: birth through 6 months (+/- 15 days) postpartum
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Change in clinician-rated depressive symptoms measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). Total scores range from 0 to 60, with higher scores indicating greater depression severity.
Time frame: Baseline, after every 5 treatments (once/week for up to 8 weeks), and 1 month after treatment
Change in Edinburgh Postnatal Depression Scale (EPDS)
Change in depressive symptoms measured using the 10-item Edinburgh Postnatal Depression Scale (EPDS). Scores range from 0 to 30, with higher scores indicating greater depressive symptom severity.
Time frame: Screening, baseline, after every 5 treatments (once/week for up to 8 weeks), and 1-month follow-up
Change in Quick Inventory of Depressive Symptomatology (QIDS)
Change in depressive symptoms measured using the Quick Inventory of Depressive Symptomatology (QIDS). Total scores for the 16-item version range from 0 to 27, with higher scores indicating more severe depression.
Time frame: Baseline, daily after each TMS treatment, and 1-month follow-up
Change in Generalized Anxiety Disorder scale (GAD-7)
Change in anxiety severity measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Scores range from 0 to 21, with higher scores indicating more severe anxiety.
Time frame: Baseline, after every 5 treatments (once/week for up to 8 weeks), and 1-month follow-up
Change in Ruminative Responses Scale (RRS)
Change in repetitive negative thinking measured using the Ruminative Responses Scale (RRS). The 22-item scale assesses rumination related to depressive symptoms, self-reflection, and brooding. Higher scores indicate greater rumination.
Time frame: Baseline, after every 5 treatments (once/week for up to 8 weeks), and 1-month follow-up
Change in Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, after every 5 treatments (once/week for up to 8 weeks), and 1-month follow-up
Change in PTSD Checklist for DSM-5 (PCL-5)
Change in posttraumatic stress symptoms measured using the PTSD Checklist for DSM-5 (PCL-5). Scores range from 0 to 80, with higher scores indicating greater symptom severity.
Time frame: Baseline, after every 5 treatments (once/week for up to 8 weeks), and 1-month follow-up
Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change in functional impairment measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Higher scores indicate greater disability or difficulty with daily functioning.
Time frame: Baseline, end of treatment (up to week 8), and 1-month follow-up
Change in Maternal Antenatal/Postnatal Attachment Scale (MAAS/MPAS)
The MAAS and MPAS are 19-item self-report questionnaires assessing maternal emotional attachment to the fetus during pregnancy (MAAS) and to the infant following birth (MPAS). The MAAS evaluates the quality and intensity of maternal attachment, while the MPAS assesses attachment quality, pleasure in interaction, and absence of hostility. Both scales yield total scores ranging from 19 to 95, with higher scores indicating stronger, more positive maternal attachment. Lower scores suggest greater difficulties with maternal-fetal or maternal-infant bonding.
Time frame: Baseline, end of treatment (up to week 8), and 1-month follow-up
Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
Proportion of participants achieving at least a 50% reduction in depressive symptom severity relative to baseline, assessed using Montgomery-Åsberg Depression Rating Scale (MADRS).
Time frame: After 20 TMS sessions (week 4), end of treatment (up to 8 weeks from baseline), and 1-month follow-up
Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
Proportion of participants meeting remission criteria, defined as MADRS score ≤10.
Time frame: After 20 TMS sessions (week 4), end of treatment (up to 8 weeks from baseline), and 1-month follow-up
Durability of Montgomery-Åsberg Depression Rating Scale (MADRS) change
Maintenance of improvement in depressive symptoms, assessed by comparing depression severity at treatment completion with Montgomery-Åsberg Depression Rating Scale (MADRS) scores obtained one month after the final TMS session.
Time frame: End of treatment (up to 8 weeks from baseline) and 1-month follow-up
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