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Accelerated iTBS for Post Partum Depression

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ClinicalTrials.gov Identifier: NCT03417960
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Constance Guille, Medical University of South Carolina

Brief Summary:
The investigators are studying the feasibility and tolerability of 6x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 3 days for women with post-partum depression. The investigators further hope to characterize the anticipated anti-depressant effect of this treatment paradigm.

Condition or disease Intervention/treatment Phase
Post Partum Depression Device: iTBS Not Applicable

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 3 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label pilot
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: iTBS
accelerated iTBS to Left DLPFC
Device: iTBS
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 6 such sessions separated by 30 minutes. 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 Measures :
  1. 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 ]
    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 :
  1. Anti-depressant effect [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417960


Contacts
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Contact: Constance Guille, MD 843-792-6489 guille@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Constance Guille, MD    843-792-6489    guille@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
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Responsible Party: Constance Guille, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03417960    
Other Study ID Numbers: Pro00073886
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Constance Guille, Medical University of South Carolina:
post partum depression
theta burst
transcranial magnetic stimulation
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications