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Recruiting NCT06559826

Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression

Phase II Interventional Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine, Psychotherapy.
Who it may be relevant to
Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression

Overview

The proposed study is a single-site, randomized, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study participants will be adults with major depressive disorder (MDD). Adults with MDD will be randomized to KAP or KET in a 1:1 allocation. Each treatment group will receive KAP or KET over a period of four weeks. Measurement of depression severity, wellness, neurocognitive functioning and other parameters will occur at baseline prior to treatment, immediately following the end of the acute treatment period, and over an 8-week (two month) treatment follow-up period.

Interventions

  • Drug Ketamine
    Following screening and baseline assessments, individuals randomized to KAP will undergo a preparatory session prior to the first day of dosing. Participants will complete a sequence of four to five intramuscular (IM) ketamine assisted therapy sessions.
  • Behavioral Psychotherapy
    Each week following KAP, there will be a separate 60-minute integration session 1-6 days afterwards. Integration sessions will focus on processing experiences and material that emerged in KAP sessions (such as assimilating challenging experiences, making meaning of experiences and imagery, working through memories and emotions, and exploring emerging relational patterns) as well as strengthening insights. Within one week of the completion of all KAP sessions, there will be one additional integra

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale (MADRS) [Time frame: 9 weeks from baseline assessment]

Eligibility criteria

Inclusion criteria

  • Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.
  • Age 18-90 years
  • Participant in good physical health
  • Participants may be on medications for depression as long as they remain on a stable dose.
  • A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity.
  • Meets criteria for major depressive disorder (MDD) in current major depressive episode (MDE) according to DSM-5
  • Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion

Exclusion criteria

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease
  • Clinically significant abnormalities of laboratories, physical examination, or ECG
  • Substance drug or alcohol use disorder in the prior 12 months
  • History of hypersensitivity to ketamine or esketamine
  • Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder
  • Presence of psychotic symptoms in the current MDE, or lifetime psychotic disorder
  • Recreational ketamine or phencyclidine use in the last year
  • Previous non-response to clinical or research ketamine or esketamine administration
  • Concurrent treatment with ECT, TMS, or VNS in the current MDE
  • BMI > 35
  • Significant suicidal ideation as determined by a C-SSRS score >2 in past 30 days
  • History of suicide attempt or self harm in the prior 2 years
  • SBP > 165 or DBP > 95 on infusion day
  • MoCA score < 23

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Identifiers

NCT: NCT06559826 · STUDY-23-00661 · PD23-03701

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗