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CompletedPhase 4Results posted

A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health

NCT05604794 · Field Trip Health

Closed to entry
Status
Not accepting participants
Phase 4
Phase
1,806
Target enrolment
11
Study sites
7 US states

What it is testing

Summary

Ketamine-Assisted Psychotherapy (KAP) is a relatively new approach for the treatment of mental health issues, which involves the combination of ketamine, a dissociative anaesthetic with psychedelic properties, and psychotherapy to promote emotional wellbeing. In this study, we investigated the effectiveness of KAP in adult patients coping with mental health. We predicted that clients would experience lasting reductions in psychological distress over time, such as depression, anxiety, and post traumatic stress, that would be detectable up to 6 months after treatment. The results of this study may provide evidence of sustained real-world effects of Ketamine-Assisted Psychotherapy, of interest to patients, clinicians, researchers, and policymakers.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • 9-item Patient Health Questionnaire (PHQ-9)

    Measured over Change from 3 months compared to baseline

  • 7-item Generalized Anxiety Disorder Measure (GAD-7)

    Measured over Change from 3 months compared to baseline

  • 6-item PTSD Checklist (PCL-6)

    Measured over Change from 3 months compared to baseline

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

19 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Written informed consent * Over the age of 18 * Should be psychologically and medically cleared by a psychiatrist, family physician, or treatment team * Diagnosed with Major Depressive Disorder (MDD), Bipolar Depression, Generalized Anxiety Disorder, Obsessive Compulsive Disorder (OCD), and Eating Disorder by a licensed healthcare practitioner (including Field Trip Consultants) * A significant history of trauma and/or formal diagnosis of PTSD as per the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) * Individuals who have received Electroconvulsive Therapy (ECT) or other neuromodulatory treatments like Transcranial Magnetic Stimulation (TMS) * Individuals reporting suicidal ideation may be included, as suicidal ideation is a symptom of a Major Depressive Episode (MDE) Exclusion Criteria: * Individuals who are unable to consent to the treatment * Pregnant women and nursing mothers --Note that Post Partum Depression (PPD) can be considered on a case-by-case basis in consultation with the National Medical Director. * There is a relative (not absolute) contraindication for individuals with a Body Mass Index (BMI) of above 35. These clients must be given thorough consideration by the medical team. * Any individual who has met DSM 5 criteria for a Substance Use Disorder in the past 3 months. * Note that patients with alcohol, opioid, benzodiazepine, cocaine, and amphetamine use disorders need to go through detox (for alcohol/benzodiazepines) and be sober for 4 weeks. * Note that mild active alcohol, cocaine, and cannabis use can be considered on a case-by-case basis at the comfort level of the treatment team if the client has demonstrated abstaining or significant reduction of use prior to starting treatment. * Daily use of moderate to high doses of benzodiazepines * Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/ mood incongruent) * Psychosis: Schizophrenia, Schizoaffective disorder, Bipolar 1 with psychotic features during mania * Active Mania: Bipolar 1 (chronic non-disruptive hypomania is an exception at the discretion of the consultant) * Borderline Personality Disorder * Uncontrolled medical disorders * Physical conditions with negative interaction with ketamine (e.g., metabolic blood disorder) * Individuals with symptomatic acute brain injury within 90 days of serious injury * Individuals diagnosed with moderate to severe sleep apnea * Individuals who are unable to identify a person or service to assure their safe transport to home post treatment

Where

11 study sites

FacilityCityRegionCountry
LA CentreLos AngelesCaliforniaUnited States
San Diego CentreSan DiegoCaliforniaUnited States
Washington DC CentreWashington D.C.District of ColumbiaUnited States
Atlanta CentreAtlantaGeorgiaUnited States
Chicago CentreChicagoIllinoisUnited States
NYC CentreNew YorkNew YorkUnited States
Houston CentreHoustonTexasUnited States
Seattle CentreSeattleWashingtonUnited States
Vancouver CentreVancouverBritish ColumbiaCanada
Fredericton CentreFrederictonNew BrunswickCanada
Field Trip Health, Toronto CentreTorontoOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05604794 on ClinicalTrials.gov →

Last updated in the registry 2024-03-20. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits