Phase 2 Depression and Anxiety Trial, Recruiting NCT06795451 Sponsor: University of Cincinnati Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT06795451
Recruiting Phase 2

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 60 years old (inclusive)
  • You are any gender (male or female)
  • You are currently experiencing a major depressive episode that has lasted at least 4 weeks but no longer than 2 years (confirmed using a standard diagnostic tool)
  • Your body weight falls within a healthy to moderately overweight range (BMI between 18.5 and 35.99)
  • Your depression symptoms score at least 18 on a standard depression rating scale called the MADRS
  • You have been taking an FDA-approved antidepressant at a steady, therapeutic dose for at least 8 weeks
  • If you are receiving talk therapy, the type and frequency has been stable for at least 4 weeks
  • You have an anxiety disorder that is no more than moderate in severity and is not your main diagnosis
  • If you are able to become pregnant, you are using an effective form of birth control
  • You are able to complete all tasks required by the study

Who may not be able to join:

  • You have already tried more than 2 antidepressant treatments (including medications or brain stimulation therapies) at proper doses during your current depressive episode without success
  • You have ever been diagnosed with bipolar disorder or a schizophrenia-related condition
  • You are considered at significant risk of suicide, or you have had suicidal behavior in the past year
  • You have experienced psychotic symptoms (such as hallucinations or delusions) during your current depressive episode or in the past 6 months
  • You currently have a substance use disorder (in the past month) — note that nicotine and caffeine use are allowed
  • You have an unstable neurological condition such as seizures (except seizures only occurring in infancy), a degenerative neurological disease, or have had a stroke
  • You have evidence of severe nerve damage in your hands or feet (confirm with trial site)
  • You have a history of moderate to severe traumatic brain injury (such as a skull fracture or being unconscious for more than 10 minutes) or a spinal cord injury
  • You have an unstable significant medical condition, such as high blood pressure that is not controlled (above 150/95 mmHg)
  • You have a history of cancer that has not been in remission for at least the past 5 years
  • You are currently taking anti-seizure medications or calcium channel blocker medications
  • You currently have a severe chronic pain condition or regularly take pain medications including NSAIDs (like ibuprofen) or opioids
  • You have any implanted electronic medical device (such as a pacemaker)
  • You have received any brain stimulation treatment in the past month
  • You have active skin sores or wounds on areas where electrodes would be placed
  • You are currently pregnant or breastfeeding
  • Your IQ is suspected to be below 80
  • There is any other clinical reason the study doctor considers makes participation unsuitable

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 30 June 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Cincinnati
Registry
ClinicalTrials.gov
Start date
25 February 2025
Est. completion
31 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

N2 peak amplitude; N2 latency

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: 30 June 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