Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression

NCT ID
NCT07247006
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
University of Rochester
Conditions
Chronic Pain, Treatment Resistant Depression (TRD)

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 25 participants (Estimated).

What is being studied

  • Intervention: Cyclohexanes
  • Intervention: Cycloparaffins
  • Intervention: Hydrocarbons
  • Intervention: Hydrocarbons, Alicyclic
  • Intervention: Hydrocarbons, Cyclic
  • Intervention: Ketamine
  • Drug: Ketamine hydrochloride injection
  • Intervention: Organic Chemicals

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria The following inclusion criteria must be met for all subjects to be considered eligible to participate: 1. 18 years old or older 2. Able to speak, read, and understand English 3. In generally stable health 4. Must have treatment resistant depression, as defined as scoring in the moderate or above range on the HDRS and having failed two adequate trials of antidepressants in the last two years. Exclusion Criteria General exclusion criteria for all subjects include: 1. Uncontrolled hypertension 2. Impaired cardiac status a. Abnormal ECG report in the last month prior to screening 3. Chronic Obstructive Pulmonary Disease 4. Congenital Long QT Syndrome 5. ≥265lbs or 120kg 6. Severe obesity (BMI ≥40) 7. Increased intracranial or cerebrospinal pressure 8. Pregnancy or breastfeeding 9. Hyperthyroidism 10. Prior adverse response to ketamine, including allergic reaction 11. Symptoms of psychosis or prodromal phase 12. Severe personality disorder 13. Autistic Spectrum Disorders 14. Bipolar disorder 15. History of substance abuse, defined as a score of three or more on Drug Abuse scale (prior use of psychedelics allowed) 16. Past-year suicide attempt or ongoing ideation with intent to act 17. All exclusion criteria for magnetic resonance imaging safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia. 18. Taking medications that could interact with ketamine. Examples include but are not limited to: any types of stimulants, aripiprazole, diphenhydramine, hydromorphone, escitalopram, fluoxetine, alprazolam, and sertraline. Each subject's current medications will be evaluated for interactions with ketamine before admission into the trial.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • University of Rochester Medical Center — Rochester, New York, 14642, United States — Site recruitment status not specified in the registry data

Study details

Start date
December 1, 2026
Primary completion date
March 1, 2028
Completion date
May 1, 2028
First posted
November 25, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07247006
Registry last updated
September 24, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07247006 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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