Depression and Anxiety Trial, Recruiting NCT05489042 Sponsor: Baylor College of Medicine Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT05489042
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:

For people with opioid use:

  • People aged 18 to 60 years old, male or female
  • People who are already taking part in a related study called H-22611
  • People whose responses to a substance use screening questionnaire (WHO-ASSIST) indicate opioid use at a score of 4 or above
  • People whose responses to a depression questionnaire (PHQ-9) indicate depressive symptoms
  • People whose responses to a suicide-related questionnaire (SBQ-R) indicate active suicidal thoughts
  • People who are able to understand, agree to, and sign a consent form, and are willing to complete all study steps
  • Female participants who are not pregnant and not breastfeeding at the time of brain scan and treatment sessions
  • People with no medical or physical reasons that would make MRI scanning unsafe (such as a pacemaker, cochlear implants, or metal in the eyes or body), and who pass the pre-screening questions from the brain imaging centre
  • People with no medical or physical reasons that would make brain stimulation treatment (TMS) unsafe (such as non-removable metal in the head, excluding the mouth, or within 12 inches of the treatment device)

For healthy volunteers (comparison group):

  • People aged 18 to 60 years old, male or female
  • People with no history of serious medical or neurological conditions
  • People who are able to understand, agree to, and sign a consent form, and are willing to complete all study steps
  • Female participants who are not pregnant and not breastfeeding at the time of brain scan sessions
  • People with no medical or physical reasons that would make MRI scanning unsafe, and who pass the pre-screening questions from the brain imaging centre
  • People with no medical or physical reasons that would make brain stimulation (TMS) unsafe

Who may not be able to join:

  • People who the clinical and research team believe are unlikely to complete the study, including those who may not be able to tolerate the brain stimulation treatment
  • People who are unable to understand how the study works or what it involves
  • People who are unable to sign a consent form for any reason
  • People with an unstable or serious medical condition, including HIV/AIDS, active hepatitis, active tuberculosis, unstable heart disease, unstable diabetes, or liver or kidney problems
  • Female participants who are pregnant or breastfeeding
  • People who have medical or physical reasons that make MRI scanning unsafe, or who do not pass the brain imaging centre's pre-screening questions
  • People who have medical or physical reasons that make brain stimulation (TMS) unsafe, including non-removable metal in the head (excluding the mouth) or within 12 inches of the treatment device
  • People who do not speak English (confirm with trial site for any updates on language support)

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 26 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: 713-275-5019

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
4 January 2022
Est. completion
28 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Functional Connectivity between the orbitofrontal cortex (OFC) and dorsal striatum in opioid users or opioid-related patients versus healthy subjects; rTMS changes in dorsal striatum responses between those receiving active stimulation versus sham stimulation

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: 26 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