Clinical trial NCT03417960: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Depression
Keywords: post partum depression
theta burst
transcranial magnetic stimulation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label pilot
Primary purpose: TREATMENT

Brief summary: Study 1: 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 aim to characterize the anticipated anti-depressant effect of this treatment paradigm.

Study 2: The investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. The investigators aim to compare the two different treatment schedules.

Detailed description: Study 1: 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 aim to characterize the ant-depressant effect of this protocol in order to design a larger trial.

Study 2: In part 2 of this study, the treatment schedule is 12 sessions over 5 days that can be completed with 8. All other procedures, inclusion/exclusion criteria, and number of total pulses delivered is the same as study 1.

Eligibility 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 year postpartum
4. Participants must have a HRSD17 greater than or equal to 14 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 eclampsia during pregnancy.

Primary outcomes:
measure: 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).
timeFrame: 7 days
Secondary outcomes:
measure: Anti-depressant effect
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: