Depression and Anxiety Trial, Recruiting NCT05437588 Sponsor: University of Alabama at Birmingham Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT05437588
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:

All participants:

  • People who are in good physical health
  • People who are willing and able to give their informed consent to take part (for those under 18, a parent or guardian must also give consent)

Participants with major depressive disorder (MDD):

  • People who have a confirmed diagnosis of major depressive disorder according to standard diagnostic guidelines (DSM-5)
  • People who score 30 or higher on a standard depression rating scale for children (CDRS-R)

Participants with suicidal thoughts:

  • People who score 4 or higher on a standard suicidal thoughts rating scale (C-SSRS), based on the past two weeks

Participants who have made a suicide attempt:

  • People who have made a suicide attempt in the past two weeks that was serious enough to need medical attention, and where a standard assessment tool shows at least a medium level of intent

Participants without a psychiatric condition (control group):

  • People with no history of any major mental health condition (except specific phobia) and no history of substance use disorder

Who may not be able to join:

  • People who are pregnant, breastfeeding, or within two months of giving birth or having a miscarriage
  • People assessed as posing a risk of harm to others, based on a clinical interview
  • People with a lifetime history of a psychotic disorder
  • People with bipolar disorder
  • People with an alcohol or drug use disorder (other than nicotine or caffeine) within the last month
  • People who have used any hallucinogen (except cannabis), including a drug called phencyclidine, in the last month
  • People with a pervasive developmental disorder (confirm with trial site)
  • People with a cognitive disorder (confirm with trial site)
  • People with paranoid, schizoid, or schizotypal personality disorders (other personality disorders may be permitted if MDD criteria are met)
  • People with anorexia nervosa
  • People who have had a recent heart attack or unstable chest pain, an active cancer diagnosis in the past 6 months, or who have received immune-suppressing or steroid medications in the past month, or chemotherapy
  • People who have had a head injury or loss of consciousness in the past 6 months
  • People who have used hallucinogens (except cannabis), methamphetamine, or cocaine in the past two weeks

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 28 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: 256-551-4431

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
1 October 2022
Est. completion
29 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Clinical phenotype analysis

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: 28 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