Accelerated iTBS for Post Partum Depression



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 50
Updated:3/16/2019
Start Date:January 24, 2018
End Date:September 1, 2019
Contact:Constance Guille, MD
Email:guille@musc.edu
Phone:843-792-6489

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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

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.

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.

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.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-6489
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