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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

NY