Phase 2 Depression and Anxiety Trial, Not Yet Recruiting NCT06376877 Sponsor: Brigham and Women's Hospital Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Not Yet Recruiting

NCT06376877
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • The person must have enough English language ability to give informed consent, complete questionnaires and tasks, and participate in treatment.
  • The person must have a diagnosis of one of the following anxiety-related conditions, confirmed by a specific screening tool (Quick-SCID): Generalised Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Post-Traumatic Stress Disorder (PTSD), or Obsessive Compulsive Disorder (OCD).
  • The person must have a moderate level of anxiety, measured by a standard anxiety scale (BAI score above 16).
  • The person must have already tried at least one psychological or medication-based treatment that did not work.
  • The person must have been on a stable psychiatric medication routine for at least 4 weeks before the trial begins, and must remain stable throughout the trial.
  • The person must have a primary care provider (such as a psychiatrist, psychologist, therapist, or similar) who is responsible for their mental health care before, during, and after the trial.
  • The person must agree to avoid becoming pregnant from the start of screening until two weeks after treatment ends (which includes the MRI visit).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who are currently pregnant, as confirmed by a urine pregnancy test.
  • People who have used fast-acting antidepressant treatments such as ketamine, esketamine, or electroconvulsive therapy (ECT) within the past 4 weeks, or who are currently using them.
  • People who have received TMS (a type of brain stimulation therapy) within the last 3 months.
  • People who have had brain surgery for a psychiatric condition.
  • People with a diagnosis of autism spectrum disorder, an intellectual disability, or a cognitive impairment that affects their ability to give informed consent.
  • People with a significant neurological illness that the trial team considers could increase the risk of harm from the treatment.
  • People with moderate to severe neurodegenerative disease (a condition where the nervous system progressively deteriorates).
  • People with an untreated or insufficiently treated hormone (endocrine) disorder.
  • People who are taking part in another research trial involving an experimental drug or treatment at the same time.
  • People with a diagnosis of Bipolar I disorder or schizophrenia.
  • People currently experiencing mania or hypomania (periods of abnormally high or elevated mood).
  • People currently experiencing psychosis (such as hallucinations or losing touch with reality).
  • People currently experiencing active thoughts of suicide with both intent and a specific plan, as defined by a standard assessment tool (the Columbia Suicide Severity Rating Scale).
  • People who have any physical reasons why they cannot safely have TMS or an MRI scan (for example, certain metallic implants in the body, or severe insomnia of more than 4 hours per night even with sleep medication) (confirm with trial site for full list).
  • People who currently have a moderate or severe substance use disorder — not including cannabis or nicotine — or who are showing signs of withdrawal from a substance.
  • People who test positive on a urine drug screen for cocaine, amphetamines, phencyclidine, or opioids, unless those substances are from a prescribed medication or a medication known to cause a false positive result.
  • People who already have tinnitus (a persistent ringing or noise in the ears).
  • People with any other condition that the lead researcher (Principal Investigator) believes could interfere with the study or put the participant at greater risk.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Principal Investigator: Shan Siddiqi, MD, Brigham and Women's Hospital

Phone: 617-525-3536

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
1 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Beck Anxiety Inventory (BAI)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov