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.
Condition or disease | Intervention/treatment | Phase |
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Postpartum Depression Antepartum Depression Peripartum Depression | Device: Transcranial Magnetic Stimulator | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) for Peri-partum Depression. |
Estimated Study Start Date : | July 1, 2021 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | April 2023 |
Arm | Intervention/treatment |
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Experimental: Open label iTBS rTMS
Participants will receive repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression
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Device: Transcranial Magnetic Stimulator
Repetitive Transcranial magnetic stimulation (rTMS) will be delivered using a MagPro X100 device with B70 coil and the intermittent theta burst (iTBS) protocol to the left dorsolateral prefrontal cortex. Participants will receive daily treatments (Monday-Friday) over four weeks
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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexander McGirr, MD, PhD | 403-210-6410 | alexander.mcgirr@ucalgary.ca |
Canada, Alberta | |
University of Calgary | Recruiting |
Calgary, Alberta, Canada, T2N 1N4 | |
Contact: Alexander o McGirr 4032106410 alexander.mcgirr@ucalgary.ca |
Principal Investigator: | Alexander McGirr, MD PhD | University of Calgary |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 6, 2019 | ||||||
First Posted Date ICMJE | May 14, 2019 | ||||||
Last Update Posted Date | January 15, 2021 | ||||||
Estimated Study Start Date ICMJE | July 1, 2021 | ||||||
Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores [ Time Frame: Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4). ] Change from baseline in severity of depressive symptoms at 2 weeks and 4 weeks as measured by the MADRS, a clinician-rated instrument. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes. The overall score ranges from 0 - 60. Cutoff points are 0-6 = normal, 7-9 = mild depression, 20-34 = moderate depression, >34 = severe depression.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | rTMS for Peripartum Depression | ||||||
Official Title ICMJE | An Open Label Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) for Peri-partum Depression. | ||||||
Brief 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. |
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Detailed 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: Transcranial Magnetic Stimulator
Repetitive Transcranial magnetic stimulation (rTMS) will be delivered using a MagPro X100 device with B70 coil and the intermittent theta burst (iTBS) protocol to the left dorsolateral prefrontal cortex. Participants will receive daily treatments (Monday-Friday) over four weeks
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Study Arms ICMJE | Experimental: Open label iTBS rTMS
Participants will receive repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression
Intervention: Device: Transcranial Magnetic Stimulator
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
30 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | April 2023 | ||||||
Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03949465 | ||||||
Other Study ID Numbers ICMJE | REB18-1175 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Calgary | ||||||
Study Sponsor ICMJE | University of Calgary | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Calgary | ||||||
Verification Date | April 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |