Depression and Anxiety Trial, Recruiting NCT05426967 Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT05426967
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:

  • People aged 18 to 55 years old at the time of signing consent forms.
  • Current or former US military service members whose care is provided at a Military Treatment Facility or Veterans Administration Medical Center.
  • People who are able to provide written informed consent in English.
  • People with a self-reported or medically diagnosed history of concussion (also called mild traumatic brain injury) that occurred more than 6 months ago but less than 26 years ago, involving a brief loss of consciousness, altered awareness, or short-term memory loss around the time of the injury.
  • People whose depression screening score indicates at least mild-to-moderate depressive symptoms at the time of screening.
  • People who have been on a stable psychiatric medication plan for at least six weeks and a stable behavioral therapy plan for at least twelve weeks before joining the study.
  • Female participants of childbearing potential who agree to use an effective form of birth control for the duration of the study.
  • People who are currently under the care of a primary care doctor and/or a mental health provider.

Who may not be able to join:

  • People with a history of unprovoked seizures, a seizure within 24 hours of a head injury, or two or more close family members (parent, sibling, or child) with a history of unprovoked seizures.
  • People with a history of moderate, severe, or penetrating traumatic brain injury (more serious than a concussion).
  • People with a growth, bleed, or other abnormality inside the skull that, in the opinion of the research team, could increase seizure risk or interfere with brain scan quality.
  • People currently taking medications or substances that, in the opinion of the research team, lower the threshold for seizures (such as certain antidepressants or antipsychotic medications).
  • People who are unable to safely have a 3T MRI scan without sedation or contrast dye, based on the radiology department's assessment at the trial site.
  • People with severe claustrophobia that would prevent them from completing a closed-bore MRI scan without medication or sedation.
  • People with a history of severe or recently uncontrolled heart disease.
  • People with a cardiac pacemaker or lines running into the heart.
  • People with any implanted device, prosthesis, or permanent body alteration that, in the opinion of the research team, would be unsafe during MRI or brain stimulation, or would interfere with scan quality.
  • People with rapidly progressing illnesses such as late-stage cancer, a neurodegenerative condition, or major organ failure.
  • People with a history of Bipolar Disorder or Schizophrenia Spectrum Disorders.
  • People currently showing signs of psychosis, mood problems caused by substance use, or depression linked to a medical condition other than a brain injury.
  • People with severe or uncontrolled substance use.
  • People who have previously received open-label TMS (transcranial magnetic stimulation) treatment at any point in their life.
  • People who have received other types of brain stimulation treatments — including tDCS, tACS, Alpha-Stim, or electroconvulsive therapy — within the 12 weeks before joining the study.
  • People who have made a suicide attempt within the six months before enrollment.
  • People with amputation of the right arm or another condition that would prevent calibration of the brain stimulation treatment on the left side of the brain.
  • People who would be unable to complete the full study timeline, for example due to a planned hospitalisation during the study period.
  • People whose freedom of movement is legally restricted, including those who are incarcerated.
  • People who, in the opinion of the research team, may have safety concerns, reliability concerns, or other factors that could affect the scientific quality of the study data.

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 27 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

Principal Investigator: David L Brody, MD, PhD, Uniformed Services University of the Health Sciences

Phone: 832-671-9532

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
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Registry
ClinicalTrials.gov
Start date
16 December 2024
Est. completion
30 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores; Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Scores in a Subgroup; Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores from Baseline to 6-month follow-up; Comparison of Treatment Response or Remission in Montgomery-Asberg Depression Rating Scale (MADRS) Scores; Comparison of Duration of Remission of Depressive Symptoms in Montgomery-Asberg Depression Rating Scale (MADRS) Scores; Comparison of Frequency of Adverse Events

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: 27 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