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Behavioural Intervention

Active Caudate for Depression (ILIAD Trial)

N/A

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18 and 65

Normal or corrected to normal vision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, pre-scan, baseline, week 1, week 2 week 3, week 4, week 5

Awards & highlights

ILIAD Trial Summary

This trial will look at how using low intensity focused ultrasound on the brain can help improve the symptoms of depression in people who have lost interest in things they used to enjoy.

Who is the study for?

This trial is for individuals who are experiencing depression with a specific symptom called anhedonia, which means they find little pleasure in things they once enjoyed. Participants should be interested in trying a non-invasive treatment that targets the brain's reward system.Check my eligibility

What is being tested?

The study is testing Low Intensity Focused Ultrasound Pulsation (LIFUP), a non-invasive method aimed at stimulating parts of the brain associated with pleasure and motivation to see if it can improve symptoms of depression and anhedonia.See study design

What are the potential side effects?

Since LIFUP is non-invasive and focuses on precise areas of the brain, side effects may be minimal but could include mild discomfort or headache during or after treatment. The full range of side effects will be studied.

ILIAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My vision is normal or corrected to normal with glasses or contacts.

ILIAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, pre-scan, baseline, week 1, week 2 week 3, week 4, week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, pre-scan, baseline, week 1, week 2 week 3, week 4, week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, pre-scan, baseline, week 1, week 2 week 3, week 4, week 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Ecological momentary assessment (EMA) from W0/Baseline

Change in Patient health questionnaire-14 self report measure (PHQ-14) from baseline

Change in Positive valence systems scale-21 self report measure (PVSS-21) from baseline

+1 more

Secondary outcome measures

Changes in digital behavioral phenotype physical activity measurement

Changes in digital behavioral phenotype sleep measurement

Changes in heart rate

+4 more

Other outcome measures

Changes in Apple Gathering task behavior from Pre-scan to end of study

Changes in Ruminative Response Scale (RRS) - brooding subscale score from W0/Baseline to end of study

Changes in Snaith Hamilton Pleasure Scale (SHAPS) score from W0/Baseline to end of study

+17 more

ILIAD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active CaudateExperimental Treatment1 Intervention

Low Intensity Focused Ultrasound Pulsation (LIFUP) will be directed at the caudate head. To minimize the ultrasound energy's exposure to air, a gel pad will be placed between the transducer and the participant's scalp. The sonication protocol will consist of 10 ultrasound sonications in a 30 s ON, 30 s OFF fashion at 650KHz, Ispta≤720 mW/cm2, 50% duty cycle, 5ms pulse width, 1.44W/cm2 ISPPA, and 100Hz pulse repetition frequency." For active sonication, the gel pad will allow the ultrasound energy to pass through. The sham/active gel pads are identical in appearance.

Group II: Sham CaudatePlacebo Group1 Intervention

Low Intensity Focused Ultrasound Pulsation (LIFUP) will be directed at the caudate head. To minimize the ultrasound energy's exposure to air, a gel pad will be placed between the transducer and the participant's scalp. The sonication protocol will consist of 10 ultrasound sonications in a 30 s ON, 30 s OFF fashion at 650KHz, Ispta≤720 mW/cm2, 50% duty cycle, 5ms pulse width, 1.44W/cm2 ISPPA, and 100Hz pulse repetition frequency." For sham sonication, the gel pad will block close to all of the ultrasound energy from the transducer from entering the brain. The sham/active gel pads are identical in appearance.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,156 Total Patients Enrolled

101 Trials studying Depression

48,397 Patients Enrolled for Depression

Wellcome TrustOTHER

214 Previous Clinical Trials

15,672,993 Total Patients Enrolled

4 Trials studying Depression

6,600 Patients Enrolled for Depression

Frequently Asked Questions

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

Are individuals aged 55 and above eligible to participate in this research study?

"Enrollment in this study is limited to individuals aged 18 and older, but not exceeding 65 years of age."

Answered by AI

Which individuals meet the eligibility criteria to participate in this research endeavor?

"Individuals aged between 18 and 65 years with a diagnosis of depression are eligible for enrollment in this study, which is accepting up to 46 participants."

Answered by AI

Are potential participants currently able to apply for this ongoing medical study?

"As per clinicaltrials.gov, the ongoing trial is not actively seeking new participants. Initially shared on October 27th, 2022 and most recently revised on February 22nd, 2024; although recruitment is paused for now. It's noteworthy that there are currently 1397 other trials enrolling patients at present."

Answered by AI

What is the primary goal of this research endeavor?

"The primary focus of this examination, to be evaluated across Week 0, Pre-scan, Baseline, and weeks 1 through 5, is the alteration in Positive Valence Systems Scale-21 self-report assessment (PVSS-21) from the initial measurement. Secondary aims encompass shifts in respiratory rate as gauged by Apple Watch & phone sensor data, modifications in Pittsburgh Sleep Quality Index (PSQI) rating from W0/Baseline until end of analysis denoted by a validated survey measuring sleep quality over multiple domains including latency and disturbances with an overall score range of 0-21 where higher scores indicate poorer sleep quality"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating LIFUP in Anhedonic Depression

Michelle Craske 2022. "Investigating LIFUP in Anhedonic Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06285474.

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