rTMS for Peripartum Depression

NCT03949465 | Withdrawn FDA Device

• 1 other identifier: REB18-1175
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression; Antepartum Depression; Peripartum Depression

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores

  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.

  Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4).

Secondary Outcomes (7)

• Rate of Clinical Remission of Depressive Symptoms

  Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)

• Rate of Clinical Response in Depressive Symptoms

  Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)

• Perinatal Anxiety Symptoms

  Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)

• Anxiety Symptoms

  Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)

• Antenatal Maternal Attachment

  If the participant is antenatal, the MAAS will be administered at baseline and after rTMS treatment (week 4).

Other Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  Daily Monday-Friday throughout study (4 weeks)

• Side Effects

  Daily Monday-Friday throughout study (4 weeks)

• Toronto Side Effects Scale (1 week) (TSES)

  Administered at baseline, halfway (week 2) and after rTMS treatment (week 4).

Study Arms (1)

Open label iTBS rTMS

EXPERIMENTAL

Participants will receive repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression

Device: Transcranial Magnetic Stimulator

Interventions

Transcranial Magnetic Stimulator DEVICE

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

Open label iTBS rTMS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women currently experiencing peripartum depression as determined by the MINI-International Neuropsychiatric Interview
• Depressive episode of at least moderate severity, as indicated by a score of ≥15 (ante-partum) or ≥12 (post-partum) on the Edinburgh Post-Natal Depression Scale (EPNDS).
• Are currently pregnant or 1 month post-delivery
• Refuse antidepressant therapy, or have depression that has not improved with psychotropics and/or psychotherapy
• Be willing to remain on a stable medication regimen for 2 weeks prior the study and during the study
• Aged 18-40 years

You may not qualify if:

• Epilepsy, history of seizures or pre-eclampsia
• Previous Stroke
• Current Alcohol Use Disorder
• History of psychosis
• Bipolar Disorder
• Current suicidal ideation
• Unstable medical condition
• history of non-response to rTMS treatment .
• have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of epilepsy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
• have concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
• have any significant obstetrical complications
• If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
• have a clinically significant laboratory abnormality, in the opinion of study physician
• are currently (or in the last 4 weeks) taking lorazepam greater than 2 mg daily (or equivalent) due to the potential to limit rTMS efficacy
• are currently (or in the last 4 weeks) taking lorazepam greater than or equal to 2 mg daily

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Alexander McGirr, MD PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 14, 2019
• Study Start: May 18, 2023
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CA (1)