Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Low-Intensity Focused Ultrasound Pulsation
- Conditions
- Major Depressive Disorder
- Sponsor
- Medical University of South Carolina
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale (MADRS) Score Change
- Status
- Suspended
- Last Updated
- 3 months ago
Overview
Brief Summary
The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging treatment with the advantage of being able to target subcortical transcranial targets, which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation. This study will investigate the effect of this stimulation on the left subgenual cingulate cortex, a highly connected node in the depression network that is correlated with clinical symptomatology.
Detailed Description
The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). Participants will receive either LIFUP or sham stimulation with crossover of sham participants into the treatment group halfway through the treatment course. The initial visit will involve consent and an MRI scan, followed by several more either active or sham treatments outside of the MRI environment delivered over the course of two days over one week. Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female
- •Age 18-70
- •Normal or corrected-to normal vision and hearing
- •Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS \>20)
- •The duration of the illness must exceed one year
- •Must be medically stable as determined by investigator
- •Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
- •History of rTMS is permitted, but not required
- •Exclusionary criteria:
- •Diagnosis of primary DSM-5 depressive disorder other than MDD
Exclusion Criteria
- Not provided
Arms & Interventions
Active/Active Group
This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).
Intervention: Low-Intensity Focused Ultrasound Pulsation
Sham/Active Group
This group will receive sham LIFUP for four treatments over one day, followed by four total treatments of active LIFUP across one day one week after sham.
Intervention: Low-Intensity Focused Ultrasound Pulsation
Sham/Active Group
This group will receive sham LIFUP for four treatments over one day, followed by four total treatments of active LIFUP across one day one week after sham.
Intervention: Sham Low-Intensity Focused Ultrasound Pulsation
Outcomes
Primary Outcomes
Montgomery-Asberg Depression Rating Scale (MADRS) Score Change
Time Frame: One week post-treatment
Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and \>35 = severe
Secondary Outcomes
- Patient Health Questionnaire (PHQ-9) Score Change(One week post-treatment)
- General Anxiety Disorder (GAD-7) Score Change(One week post-treatment)