Phase 2 Depression and Anxiety Trial, Recruiting NCT06419439 Sponsor: VA Office of Research and Development Condition: Depression and Anxiety
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Phase 2 Depression and Anxiety Trial, Recruiting

NCT06419439
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:

  • People who are veterans and report moderate to severe chronic low back pain that has been present on most days for at least 3 months, with a pain score of at least 4 out of 10, and where the pain significantly interferes with daily life.
  • People who are currently experiencing significant symptoms of depression, based on a score of 11 or higher on a standard depression questionnaire called the QIDS-SR.
  • People who have been medically stable, meaning no hospital stays lasting 3 or more days in the past month.
  • People whose pain or depression medications have not changed in the past 4 weeks.
  • People who have no planned surgeries, injections, hospital stays, or new treatments for back pain (other than physical therapy or exercise) or depression in the next four months.
  • People who have an adult available to drive them home after ketamine treatment sessions.

Who may not be able to join:

  • People who are not able to speak English, as the study involves a program conducted in English.
  • People who are unable or unwilling to sign a written consent form (for example, due to current confusion or disorientation).
  • People who currently have psychotic symptoms, or who have a history of schizophrenia, schizoaffective disorder, or another psychotic disorder.
  • People who are currently taking part in another clinical trial for pain or depression.
  • People with uncontrolled high blood pressure (systolic above 160 mmHg and/or diastolic above 100 mmHg).
  • People with known increased pressure in the brain or eye, or a brain artery aneurysm.
  • People with a history of liver cirrhosis or an unstable heart condition, such as severe heart failure.
  • People whose blood test results for certain liver, kidney, or thyroid markers fall significantly outside the normal range (confirm with trial site for specific values).
  • People who test positive for pregnancy, or people of childbearing potential who are not using a birth control method.
  • People with a known allergic sensitivity to any ingredient in the ketamine injection used in this trial.
  • People who have previously had serious side effects from ketamine.
  • People who test positive for non-prescribed substances (other than cannabis) on the day of a ketamine infusion session.
  • People with a current or past history of ketamine misuse or abuse.

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 21 July 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.

Contact this trial

Principal Investigator: Victoria D Powell, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Phone: (734) 845-3072

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
Phase 2
Registry
ClinicalTrials.gov
Start date
3 December 2025
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)

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: 21 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