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rTMS for Peripartum Depression

Primary Purpose

Postpartum Depression, Antepartum Depression, Peripartum Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulator
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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 .
  • 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

Sites / Locations

  • University of Calgary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label iTBS rTMS

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Clinical Remission of Depressive Symptoms
Number of participants with a score of </= 10 on the MADRS
Rate of Clinical Response in Depressive Symptoms
Number of participants with a >/= 50% reduction in MADRS scores
Perinatal Anxiety Symptoms
Perinatal Anxiety symptoms will be assessed using the Perinatal Anxiety Screening Scale (PASS). The PASS measures self-reported feelings of anxiety in the peripartum period. PASS scores range from 0-93, interpretations are as follows: 0-20 = asymptomatic, 21-41 = mild-moderate symptoms, and 42-93 = severe symptoms.
Anxiety Symptoms
The State-Trait Anxiety Inventory (STAI) measures self reported feelings of extrinsic "state" anxiety and intrinsic "trait" anxiety. The STAI scores range from 20-80, with higher scores correlating to greater anxiety.
Antenatal Maternal Attachment
The Maternal Antenatal Attachment Scale (MAAS) assesses self-reported feelings of the mother-child relationship before birth. Scores range from 19-95 on the MAAS, with lower scores representing lower levels of attachment.
Postnatal Maternal Attachment
The Maternal Postnatal Attachment Scale (MPAS) assesses self-reported feelings of the mother-child relationship after birth. Scores range from16-80 on the MPAS, with lower scores representing lower levels of attachment.
Quick Inventory of Depressive Symptomatology- Self-report (QIDS-SR)
The QIDS -SR is a self-reported measure of depressive symptoms. Total scores range from 0 to 27, with higher scores representing greater severity of depression. Score interpretations are as follows: 0-7 = normal, 8-12 = mild, 13-16 = moderate, 17-20 = moderate to severe, 21-27 = severe.

Full Information

First Posted
May 6, 2019
Last Updated
September 8, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT03949465
Brief Title
rTMS for Peripartum Depression
Official Title
An Open Label Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) for Peri-partum Depression.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment remains at zero.
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
May 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Antepartum Depression, Peripartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label iTBS rTMS
Arm Type
Experimental
Arm Description
Participants will receive repetitive transcranial magnetic stimulation (rTMS) as a treatment for depression
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulator
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores
Description
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.
Time Frame
Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4).
Secondary Outcome Measure Information:
Title
Rate of Clinical Remission of Depressive Symptoms
Description
Number of participants with a score of </= 10 on the MADRS
Time Frame
Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Title
Rate of Clinical Response in Depressive Symptoms
Description
Number of participants with a >/= 50% reduction in MADRS scores
Time Frame
Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Title
Perinatal Anxiety Symptoms
Description
Perinatal Anxiety symptoms will be assessed using the Perinatal Anxiety Screening Scale (PASS). The PASS measures self-reported feelings of anxiety in the peripartum period. PASS scores range from 0-93, interpretations are as follows: 0-20 = asymptomatic, 21-41 = mild-moderate symptoms, and 42-93 = severe symptoms.
Time Frame
Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Title
Anxiety Symptoms
Description
The State-Trait Anxiety Inventory (STAI) measures self reported feelings of extrinsic "state" anxiety and intrinsic "trait" anxiety. The STAI scores range from 20-80, with higher scores correlating to greater anxiety.
Time Frame
Administered at baseline, at the halfway point (week 2), and after rTMS treatment (week 4)
Title
Antenatal Maternal Attachment
Description
The Maternal Antenatal Attachment Scale (MAAS) assesses self-reported feelings of the mother-child relationship before birth. Scores range from 19-95 on the MAAS, with lower scores representing lower levels of attachment.
Time Frame
If the participant is antenatal, the MAAS will be administered at baseline and after rTMS treatment (week 4).
Title
Postnatal Maternal Attachment
Description
The Maternal Postnatal Attachment Scale (MPAS) assesses self-reported feelings of the mother-child relationship after birth. Scores range from16-80 on the MPAS, with lower scores representing lower levels of attachment.
Time Frame
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.
Title
Quick Inventory of Depressive Symptomatology- Self-report (QIDS-SR)
Description
The QIDS -SR is a self-reported measure of depressive symptoms. Total scores range from 0 to 27, with higher scores representing greater severity of depression. Score interpretations are as follows: 0-7 = normal, 8-12 = mild, 13-16 = moderate, 17-20 = moderate to severe, 21-27 = severe.
Time Frame
Administered at baseline, halfway (week 2) and after rTMS treatment (week 4). All participants will complete the QIDS-SR at 8 weeks postpartum.
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Adverse events will be tracked and recorded
Time Frame
Daily Monday-Friday throughout study (4 weeks)
Title
Side Effects
Description
Side effects will be tracked through a comfort rating questionnaire. The comfort rating questionnaire assesses the frequency and severity of side effects common to rTMS treatment. Severity of individual side effects are rated from 1 (none) to 10 (extreme).
Time Frame
Daily Monday-Friday throughout study (4 weeks)
Title
Toronto Side Effects Scale (1 week) (TSES)
Description
The Toronto Side Effects Scale measures frequency and severity of a variety of side effects over the past week. Frequency and severity of each symptom are rated on a scale of 1 - 5, with higher scores corresponding to more frequent/severe symptoms.
Time Frame
Administered at baseline, halfway (week 2) and after rTMS treatment (week 4).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 . 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander McGirr, MD PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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rTMS for Peripartum Depression

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