Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07247006
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain
  • Treatment Resistant Depression (TRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketamine hydrochloride injection — DRUG
    0.5-1mg/kg intramuscular (IM) injection of ketamine

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TRD group

Primary Outcome Measure

Proportion of Participants Retained in Study Through 2-Month Follow-Up [ Time Frame: 2 months post-enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14642
Paul Geha, MD
[email protected]
(585)-275-8675
Paul Geha, MD (PRINCIPAL_INVESTIGATOR)
Marc Swogger, PhD (PRINCIPAL_INVESTIGATOR)

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