rTMS for Peripartum Depression

Status Withdrawn

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

Clinical Trial Details

NCT number	NCT03949465
Study type	Interventional
Source	University of Calgary
Contact
Status	Withdrawn
Phase	N/A
Start date	May 18, 2023
Completion date	May 18, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06348316` - Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies	N/A
Recruiting	`NCT05322161` - Yoga in the NICU for Parents Study	N/A
Withdrawn	`NCT03709004` - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression	N/A
Completed	`NCT06305325` - Coparenting Intervention to Prevent Postpartum Depression	N/A
Not yet recruiting	`NCT05055674` - The Effects of Motherly on Postpartum Depression	N/A
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
Completed	`NCT04146025` - Nurtured in Nature	N/A
Recruiting	`NCT05137925` - Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum	N/A
Not yet recruiting	`NCT05299398` - Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone	Phase 1
Completed	`NCT04925765` - Virtual Reality Biofeedback for Postpartum Anxiety and Depression	N/A
Recruiting	`NCT06053515` - Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication	N/A
Completed	`NCT04037085` - Ketamine to Improve Recovery After Cesarean Delivery - Part 1	Phase 2
Completed	`NCT05059600` - A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting	Phase 4
Recruiting	`NCT06136520` - The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression	N/A
Recruiting	`NCT05038085` - Postpartum Depression and Maternal Attachment	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.