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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