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NCT07247006 · ClinicalTrials.gov registry record · Phase 2
Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression
A Phase 2 study, sponsored by University of Rochester.
- Not yet
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT07247006 is a Phase 2 study that has not yet begun recruiting, run by University of Rochester. The registered enrollment target is 25 participants.
The verdict
NCT07247006, a Phase 2 study, has not yet begun recruiting, sponsored by University of Rochester.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
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 be
Interventions
- DRUG Ketamine hydrochloride injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07247006
The ClinicalTrials.gov registry entry for NCT07247006 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketamine hydrochloride injection is the first listed.
NCT07247006 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07247006 about?
NCT07247006 is a clinical study titled "Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression". 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 ...
What is the current status of trial NCT07247006?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2026-06. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07247006?
The interventions under investigation include: Ketamine hydrochloride injection (DRUG).
Who is sponsoring clinical trial NCT07247006?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
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