An Open Label Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) for Peri-partum Depression.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postpartum Depression
- Sponsor
- University of Calgary
- Locations
- 1
- Primary Endpoint
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Epilepsy, history of seizures or pre-eclampsia
- •Previous Stroke
- •Current Alcohol Use Disorder
- •History of psychosis
- •Bipolar Disorder
- •Current suicidal ideation
- •Intracranial metallic objects (dental hardware is not an exclusionary criteria)
- •Unstable medical condition
- •have failed a course of ECT in the current episode. Previous ECT treatment outside of the current episode does not influence inclusion.
- •history of non-response to rTMS treatment .
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Antenatal Maternal Attachment(If the participant is antenatal, the MAAS will be administered at baseline and after rTMS treatment (week 4).)
- Quick Inventory of Depressive Symptomatology- Self-report (QIDS-SR)(Administered at baseline, halfway (week 2) and after rTMS treatment (week 4). All participants will complete the QIDS-SR at 8 weeks postpartum.)
- Rate of Clinical Remission of Depressive 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))
- Postnatal Maternal Attachment(If the participant is postnatal, the scale will be administered at baseline and after rTMS treatment (week 4). All participants will complete the MPAS at 8 weeks postpartum.)
- 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))