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Accelerated iTBS for Post Partum Depression

Primary Purpose

Post Partum Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iTBS
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Depression focused on measuring post partum depression, theta burst, transcranial magnetic stimulation

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Participants must be over the age of 18.
  3. Participants must meet criteria for post-partum depression: a) onset of symptoms in the first four weeks postpartum OR b) depressive symptoms starting in the third trimester and worsening postpartum.
  4. Participants must have a HRSD17 >13 at baseline.

Exclusion Criteria:

  1. Participants must not be pregnant.
  2. Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder.
  3. Participants must not have current psychotic symptoms.
  4. Participants must not have a history of dementia or other cognitive impairment.
  5. Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months.
  6. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion).
  7. Participants must not have any unstable general medical conditions.
  8. Participants must not have had pre-eclampsia or eclampsia during pregnancy.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iTBS

Arm Description

accelerated iTBS to Left DLPFC

Outcomes

Primary Outcome Measures

Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).
Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).

Secondary Outcome Measures

Anti-depressant effect
Determine the preliminary anti-depressant effect size of a course of accelerated iTBS for women with postpartum depression. He hope to find at least 30% of post-partum depressed subjects receiving accelerated iTBS will achieve a response (50% reduction in symptoms as measured on Ham-D) at 4 weeks.

Full Information

First Posted
January 24, 2018
Last Updated
August 18, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03417960
Brief Title
Accelerated iTBS for Post Partum Depression
Official Title
An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

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
Yes

5. Study Description

Brief Summary
The investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. The investigators further hope to characterize the anticipated anti-depressant effect of this treatment paradigm.
Detailed Description
This is an open-label study designed to investigate the feasibility and tolerability of a novel TMS treatment protocol to treat depression in women with post-partum depression. It is known that TMS can effectively treat depression. The FDA approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. The investigators are investigating a 6 day treatment for depression which may be more acceptable for this population. The investigators further hope to characterize the ant-depressant effect of this protocol in order to design a larger trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression
Keywords
post partum depression, theta burst, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTBS
Arm Type
Experimental
Arm Description
accelerated iTBS to Left DLPFC
Intervention Type
Device
Intervention Name(s)
iTBS
Intervention Description
The investigators will treat post-partum depressed subjects with accelerated intermittent theta burst stimulation. iTBS will be delivered via a MagVenture MagPro100 and Cool-B65 coil. The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. The accelerated paradigm will consist of 10 such sessions separated by 15 minutes, for three treatment days per week. There will be 2 weeks of 10 sessions on each of three days for a total of six treatment days, divided by one treatment-free week between treatment weeks. Treatments will be delivered at the 10-20 EEG coordinate for F3 (approximating the left DLPFC), and will be found using the Beam-F3 method.
Primary Outcome Measure Information:
Title
Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).
Description
Determine feasibility and tolerability of accelerated iTBS for postpartum depression. The investigators hope to retain >80% of recruited patients (feasibility) and reach a full treatment dose of 120%rMT in >80% of enrolled women (tolerability).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Anti-depressant effect
Description
Determine the preliminary anti-depressant effect size of a course of accelerated iTBS for women with postpartum depression. He hope to find at least 30% of post-partum depressed subjects receiving accelerated iTBS will achieve a response (50% reduction in symptoms as measured on Ham-D) at 4 weeks.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. Participants must be over the age of 18. Participants must meet criteria for post-partum depression: a) onset of symptoms in the first four weeks postpartum OR b) depressive symptoms starting in the third trimester and worsening postpartum. Participants must have a HRSD17 >13 at baseline. Exclusion Criteria: Participants must not be pregnant. Participants must not meet moderate or severe use disorder of any substance with the exception of Tobacco Use Disorder. Participants must not have current psychotic symptoms. Participants must not have a history of dementia or other cognitive impairment. Participants must not have active suicidal ideation requiring hospitalization or a suicide attempt within the past 3 months. Participants must not have any contraindications to receiving rTMS (e.g. metal implanted above the neck, history of seizure, any known brain lesion). Participants must not have any unstable general medical conditions. Participants must not have had pre-eclampsia or eclampsia during pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa McTeague, PhD
Phone
843-792-8274
Email
mcteague@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa McTeague, PhD
Phone
843-792-8274
Email
mcteague@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Accelerated iTBS for Post Partum Depression

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