Depression and Anxiety Trial, Recruiting NCT06968390 Sponsor: Brigham and Women's Hospital Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT06968390
Recruiting Not Applicable

Who may 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 might be able to join this trial:

  • You are between 18 and 55 years old
  • You are between 14 and 34 weeks pregnant, or within one year of having given birth, at the time treatment starts
  • You are able to understand and communicate in English well enough to give consent, complete questionnaires, and take part in treatment
  • You have been diagnosed with major depressive disorder that is moderate to severe and has not responded well to previous treatments (confirm with trial site for exact scoring thresholds)
  • You have been on a stable antidepressant medication plan — or no medication at all — for at least 4 weeks before treatment, and are willing to keep it the same throughout the study and ideally for one month after
  • You have a primary care provider managing your mental health (such as a psychiatrist, therapist, or similar) as well as a separate provider managing your pregnancy care
  • You are willing to keep your usual intake of caffeine-containing food and drinks (such as coffee, tea, soft drinks, and chocolate) the same throughout the treatment

Who may not be able to join:

  • You are currently using fast-acting antidepressant treatments such as ketamine, esketamine, or electroconvulsive therapy (ECT)
  • You are currently receiving, or planning to receive, other TMS (transcranial magnetic stimulation) treatments during the study
  • You have pregnancy-related complications such as preeclampsia or frequent painful contractions (more than one every 10 minutes)
  • You have a history of brain surgery for depression, autism spectrum disorder, intellectual disability, severe memory or thinking problems, or a significant neurological condition such as epilepsy, dementia, Parkinson's disease, a brain tumour, or multiple sclerosis (confirm full list with trial site)
  • You have an untreated or poorly managed hormone/gland disorder (confirm with trial site)
  • Your depression symptoms changed by 30% or more between your initial screening and your baseline assessment
  • You are currently experiencing mania, psychosis, or have had a recent suicide attempt or active suicidal thoughts with a plan within the past 3 months
  • You have anything that would make MRI or TMS scans unsafe, such as certain metal implants (confirm with trial site)
  • You currently have a moderate or severe substance use disorder or are going through substance withdrawal
  • You have ringing in the ears (tinnitus) that affects your daily life
  • You have a history of a detached retina or other serious eye condition affecting the retina
  • You have been diagnosed with severe borderline personality disorder
  • You have any other condition that the study doctor believes could interfere with the study or put you at greater risk (confirm with trial site)

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 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

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
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
5 August 2025
Est. completion
30 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Tolerability as measured by ratings of the Client Satisfaction Questionnaire (CSQ-8); Acceptability as measured by percentage of individuals who complete an entire treatment course; Safety as measured by reports of adverse events; Feasibility as measured by the number of individuals treated throughout the study

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: 15 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