Clinical trial for Depression
Official title Focused Ultrasound for Behavioral Health
ClinicalTrials.gov ID: NCT07851038
What this study is testing
- What it's testing
- This study is testing whether focused ultrasound can be safe and may help people with depression, anxiety, or OCD. It also looks at how much stimulation is needed.
- Who it's for
- You may be able to join if you are an adult with mild to moderate depression, anxiety, or OCD and you are not taking other brain‑stimulation treatments.
- What's involved
- You will receive ultrasound treatments at a clinic. Each visit you will sit in a chair while the machine sends gentle sound waves to your brain. Staff will ask you questions about how you feel, but they will not know which brain area is being targeted or the exact settings used.
- Time commitment
- The study lasts a few weeks and requires several treatment visits, plus brief check‑in appointments.
You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- Be between 22 and 80 years of age (inclusive) on the day of signing informed consent.
- Have at least one of the following at screening: PHQ-9 total score 5-16 (depression), GAD-7 total score 5-14 (anxiety), or OCI-R total score 14-27...
- If currently taking psychiatric medication, have been on the same stable dose(s) for at least 4 weeks prior to screening and be willing to maintain...
- Be able and willing to undergo a multi-sequence cranial MRI.
- Be willing to use the ATTN201 device during stimulation visits and to attempt use of monitoring devices (optional ambulatory EEG system, smart watch)...
You likely can't join if
- Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (ideation with intent, with or without plan) at screening.
- Any suicide attempt within the past 12 months.
- Any change in psychiatric medication (start, stop, or dose change) within 4 weeks prior to screening.
- Has an unstable or severe medical or psychiatric condition that, in the investigator's judgment, would pose a safety risk to the participant or...
- Has an active, unstable substance use disorder including alcohol use disorder in the past 6 months (except for caffeine and nicotine).
- Has a history of moderate-to-severe traumatic brain injury, or mild traumatic brain injury within the past 12 months.
See the full eligibility criteria
Who can join
- Be between 22 and 80 years of age (inclusive) on the day of signing informed consent.
- Have at least one of the following at screening: PHQ-9 total score 5-16 (depression), GAD-7 total score 5-14 (anxiety), or OCI-R total score 14-27 (obsessive-compulsive disorder).
- If currently taking psychiatric medication, have been on the same stable dose(s) for at least 4 weeks prior to screening and be willing to maintain the regimen throughout the treatment period.
- Be able and willing to undergo a multi-sequence cranial MRI.
- Be willing to use the ATTN201 device during stimulation visits and to attempt use of monitoring devices (optional ambulatory EEG system, smart watch) during the pre- and post-stimulation monitoring blocks
- Sign the informed consent form, in accordance with local requirements, after the scope and nature of the investigation have been explained to the participant, and before any screening assessments.
- Be able to speak, read, and understand English.
- Be able to use a smartphone and the Attune platform.
- Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
- Be able to adhere to the treatment protocol and visit schedules through the 3-month post-treatment follow-up.
- Be judged by the investigator as likely to comply with study procedures and willing to participate in the entirety of the study.
- Be determined by the investigator to be medically stable at baseline as assessed by medical history and non-significant clinical results of a vital signs examination.
- Male participants must ensure a condom is used for all sexual intercourse and follow acceptable methods of contraception for their female partner for the entire duration of the study and for 90 days after the final...
- Female participants who are sexually active agree to use two methods of contraception for the duration of the study and for 30 days after the final study visit, or not be of childbearing potential as indicated by...
What rules you out
- Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (ideation with intent, with or without plan) at screening.
- Any suicide attempt within the past 12 months.
- Any change in psychiatric medication (start, stop, or dose change) within 4 weeks prior to screening.
- Has an unstable or severe medical or psychiatric condition that, in the investigator's judgment, would pose a safety risk to the participant or prevent completion of study procedures.
- Has an active, unstable substance use disorder including alcohol use disorder in the past 6 months (except for caffeine and nicotine).
- Has a history of moderate-to-severe traumatic brain injury, or mild traumatic brain injury within the past 12 months.
- Has a history of seizure disorder or epilepsy, or any structural CNS lesion known to lower seizure threshold.
- Has any contraindications for completing a brain MRI scan (e.g., pacemaker, ferromagnetic implants).
- Body mass index (BMI) greater than 40 kg/m².
- Is pregnant, is attempting to become pregnant, or is nursing.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or Sponsor staff member directly involved with this trial.
- Has a known allergy or sensitivity to ultrasound gel, silicone, or adhesive materials used in monitoring devices.
- Has an active skin condition at sensor placement sites that would prevent device wear.
- Has received an investigational drug or device in another clinical study within 30 days before screening
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.