Clinical Trials Logo

Clinical Trial Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulatory technique that is effective in major depression. There is preliminary evidence suggesting that rTMS is effective in peripartum depression as well, however this comes from a number of very small studies.

The objective is to study the effectiveness of rTMS in peripartum depression. The investigators will do so using an open label design in which participants will receive rTMS for four weeks. The focus is on clinical improvement in depressive symptoms; however the investigators will also look at other aspects such as perinatal anxiety and maternal-infant bonding as measured by self-report questionnaires.


Clinical Trial Description

Peripartum Depression (PPD) is common and severely disabling. Pharmacological intervention remains the first line of treatment, however many patients do not experience any benefits from them. Furthermore, many women are hesitant about pharmaceutical interventions due to the unknown effects on foetal health and lactation. Hence novel treatment approaches are required for such patients. Neuromodulation techniques involve selective targeting of brain areas which are promising avenues for such depressed patients.

Transcranial magnetic stimulation (rTMS) is an investigational and therapeutic modality that impacts neurons by delivering patterned energy safely and noninvasively. In response to this patterned energy, neurons fire, and adapt by changing their connection strengths. This change in connection strength is believed to be the underlying mechanism whereby rTMS has therapeutic benefit in conditions such as Major Depressive Disorder (MDD). There are preliminary evidences suggesting that it is effective in PPD as well, however this comes from a number of very small studies and is therefore unclear.

Given the promising preliminary evidence, the investigators propose to study the effectiveness of intermittent Theta-Burst Stimulation rTMS (iTBS) to the left dorsolateral prefrontal cortex (DLPFC) in treating PPD. Participants with PPD will receive iTBS rTMS for four weeks (20 sessions) in an open label manner. The primary measure will be clinical improvement in depressive symptoms as measured by change in the Montgomery-Asberg Depression Rating Scale (MADRS) with iTBS-rTMS. In addition, the investigators will look at other aspects such as peripartum anxiety and maternal attachment during treatment and 8 weeks postpartum. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03949465
Study type Interventional
Source University of Calgary
Contact Alexander McGirr, MD, PhD
Phone 403-210-6410
Email alexander.mcgirr@ucalgary.ca
Status Not yet recruiting
Phase Phase 4
Start date July 2019
Completion date April 2023

See also
  Status Clinical Trial Phase
Completed NCT02285504 - Evaluate SAGE-547 in Female Patients With Severe Postpartum Depression Phase 2
Enrolling by invitation NCT02323152 - PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK N/A
Not yet recruiting NCT01658098 - Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez N/A
Completed NCT00961402 - The Effect of Exercise on Preventing PostPartum Depression Phase 2
Completed NCT01312883 - Mothers Avoiding Depression Through Empowerment Intervention Trial N/A
Completed NCT00360204 - Improving Health Outcomes for New Mothers and Babies Phase 3
Unknown status NCT00548743 - Translating Research Into Practice for Postpartum Depression N/A
Terminated NCT02272387 - Is Vitamin D Insufficiency and Deficiency Associated With Antepartum and Postpartum Depression? N/A
Completed NCT01977326 - Task Sharing Counseling Intervention by Community Health Workers for Prenatal Depression in South Africa N/A
Completed NCT00942721 - Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression Phase 1
Recruiting NCT03283254 - PREPP: Preventing Postpartum Depression N/A
Recruiting NCT03615794 - A Study of Pregnant and Postpartum Women With and Without Mood Disorders
Terminated NCT01328613 - A Prospective Study of Postpartum Depression in Women With Major Depression
Completed NCT03336541 - Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression Phase 4
Completed NCT01744041 - Mommy-Baby Treatment for Perinatal Depression N/A
Completed NCT01463202 - Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression Phase 4
Completed NCT00782912 - Postpartum Anemia and Postpartum Depression
Completed NCT02391870 - The Staying Well Study: An Open Trial of Mindfulness-Based Cognitive Therapy for the Prevention of Perinatal Depression N/A
Completed NCT01453114 - Cognitive-Behavioral Therapy (CBT) in Women Discontinuing Antidepressant for Pregnancy N/A
Completed NCT00298311 - Effect of Home-Based Peer Support on Maternal-Infant Interaction and Postpartum Depression N/A