Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06013384
Other study ID # Pro00128763
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 16, 2024
Est. completion date June 2025

Study information

Verified date February 2024
Source Medical University of South Carolina
Contact Charles Palmer, MD
Phone 8436979989
Email palmecha@musc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 - Anxiety disorders such as GAD are permitted as long as MDD is primary - Diagnosis of schizophrenia or bipolar disorder - Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD) - Contraindication to enter the MRI environment. - Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). - Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. - Inability to adhere to treatment schedule. - Initiation of new antidepressant treatment at the time of study randomization.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Low-Intensity Focused Ultrasound Pulsation
Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels in treatment sessions one and two.
Sham Low-Intensity Focused Ultrasound Pulsation
Sham low-intensity focused ultrasound pulsation will be given.

Locations

Country Name City State
United States 30 Bee Street Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery-Asberg Depression Rating Scale (MADRS) Score Change Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and >35 = severe One week post-treatment
Secondary Patient Health Questionnaire (PHQ-9) Score Change Change in PHQ-9 Score, which ranges from 0-27, with 0-4 = no depression; 5-9 = mild; 10-14 = moderate; and >15 = severe One week post-treatment
Secondary General Anxiety Disorder (GAD-7) Score Change Change in GAD-7 Score, which ranges from 0-21, with 0-4 = no anxiety; 5-9 = mild; 10-14 = moderate; and >15 = severe One week post-treatment
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A