NCT07247006Not yet recruitingPhase 2
Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
The goal of this clinical trial is to understand the effect of ketamine on the brain in people with treatment-resistant depression (TRD). TRD occurs in around a third of people with depression and leads to higher suicide rates compared to those with major depressive disorder. A desperate need for a rapid acting antidepressant drug (RAAD) is needed to help improve quality of life for people with TRD. Ketamine has been shown to be a RAAD, and esketamine (a form of ketamine) was approved by the FDA to treat TRD. Ketamine has been known to cause dissociative experiences, that can lead to an increase in the "Openness to Experience" personality trait and psychological flexibility that occurs at "peak experience". This has been shown to improve mental health conditions and lower suicide risk. This study aims to further understand if there is a connection between this new change of mind and changes in brain activity. Ketamine has been shown to improve brain plasticity as well, specifically in the frontolimbic region of the brain, an area associated with depression. The investigators are analyzing the brain using functional magnetic resonance imaging (fMRI), a method used to measure brain activity. The frontolimbic region is also associated with cognitive flexibility and emotional processing, an important hurdle in treating TRD. Due to this, the investigators are pairing the ketamine treatment with psychotherapy sessions, to guide the processing experience, which can lead to higher emotional flexibility. The main questions this study aims to answer are: * Are frontolimibic plasticity circuitry changes associated with openness to experience and peak experience? * Is it feasible to recruit and retain people through a two-month KAP study? * Is the structure of the study effective for treating TRD? Participants will: * Visit the facilities 6-8 times * Complete 2 MRI brain scans * Complete 3-4 psychotherapy sessions * Receive 1-2 doses of ketamine * Complete online surveys between 3-4 visits
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 6 Nov 2025
- Start date
- Dec 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- University of Rochester
- Diseases
- Depression
- NCT number
- NCT07247006
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From Dec 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Impaired cardiac status
- Abnormal ECG report in the last month prior to screening
- Prior adverse response to ketamine, including allergic reaction
- History of substance abuse, defined as a score of three or more on Drug Abuse scale (prior use of psychedelics allowed)
- All exclusion criteria for magnetic resonance imaging safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia.
- 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.
Other illness
- Uncontrolled hypertension
- Chronic Obstructive Pulmonary Disease
- Severe personality disorder
- Autistic Spectrum Disorders
- Bipolar disorder
Lab values
- Congenital Long QT Syndrome
Other
- General exclusion criteria for all subjects include:
- ≥265lbs or 120kg
- Severe obesity (BMI ≥40)
- Increased intracranial or cerebrospinal pressure
- Pregnancy or breastfeeding
- Hyperthyroidism
- Symptoms of psychosis or prodromal phase
- Past-year suicide attempt or ongoing ideation with intent to act
Who the study is looking for
- The following inclusion criteria must be met for all subjects to be considered eligible to participate:
- 18 years old or older
- Able to speak, read, and understand English
- In generally stable health
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.