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Behavioural Intervention

Sham/Active Group for Major Depressive Disorder

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal or corrected-to normal vision and hearing
Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS >20)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week post-treatment
Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of a new treatment called LIFUP for severe depression in a small group of ten patients. LIFUP can target specific areas in the brain that are

Who is the study for?
This trial is for adults aged 18-70 with major depressive disorder (MDD) that's moderate to severe and hasn't improved after trying at least two SSRI treatments and one additional therapy. People with anxiety can join if MDD is their main issue, but not those with schizophrenia or bipolar disorder. Participants need stable health, normal vision and hearing (with aids if needed), and a history of depression lasting over a year.Check my eligibility
What is being tested?
The study tests Low-Intensity Focused Ultrasound Pulsation (LIFUP) on the left subgenual cingulate cortex in the brain to see if it helps people who haven't gotten better from standard depression treatments. It compares real LIFUP treatment against sham (fake) treatment in ten patients to check its safety and effectiveness.See study design
What are the potential side effects?
Since LIFUP is an emerging treatment, specific side effects are being studied; however, similar procedures like transcranial magnetic stimulation may cause headaches or discomfort at the stimulation site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision and hearing are normal, or corrected to be normal.
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I have been diagnosed with severe depression.
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I have tried and not responded to two SSRIs and one additional treatment.
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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and one week post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale (MADRS) Score Change
Secondary outcome measures
General Anxiety Disorder (GAD-7) Score Change
Patient Health Questionnaire (PHQ-9) Score Change

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham/Active GroupExperimental Treatment2 Interventions
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.
Group II: Active/Active GroupExperimental Treatment1 Intervention
This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,626 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participating in this clinical trial?

"Individuals aged between 18 and 70 with a diagnosis of major depressive disorder are eligible for participation in this research. Approximately 10 participants are sought for the study."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, the details on clinicaltrials.gov affirm that this investigation is actively enrolling subjects. The trial was initially published on February 16th, 2024 and last revised on the same date. It aims to recruit 10 participants from a single site."

Answered by AI

What is the overall participant count in this clinical study?

"Affirmative. Information available on clinicaltrials.gov indicates that this particular medical research investigation is actively in search of suitable candidates. The trial was initially disclosed on 2/16/2024 and had its latest update on the same day. At present, the study aims to enroll 10 participants at a single designated site."

Answered by AI

Is the research trial open to individuals younger than 45 years old?

"Participants aged between 18 and 70 are eligible for enrollment in this study. There are a total of 222 trials catering to individuals under 18 years old, while there is availability of 1027 trials specifically targeting the elderly population over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
30 Bee Street
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Low-Intensity Focused Ultrasound for Treatment-Resistant Depression
Charles Palmer 2024. "Low-Intensity Focused Ultrasound for Treatment-Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06013384.
All > Focused Ultrasound
~7 spots leftby Dec 2024
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