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

Retrospective Review of Ketamine Assisted Psychotherapy Program on Mental Health at Field Trip Health Centres in North America

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Post Traumatic Stress Disorder
• Intervention / Treatment: Combination product: Ketamine-Assisted Psychotherapy (KAP)

Detailed Description

Background: Ketamine-Assisted Psychotherapy (KAP) has shown positive effects within clinical trial settings and over short-term follow-ups, but sustained effects in real-world treatment settings remain unclear. In this study, we investigated the effectiveness of KAP in adult patients coping with mental health issues. We hypothesized that there would be significant reductions in psychological distress over time.

Objective: To examine treatment effects at 1, 3, and 6 months relative to baseline on depression, anxiety, and post traumatic stress outcomes.

Design: A retrospective intervention-only effectiveness trial.

Setting: KAP was administered across 11 Field Trip Health clinics in North America. Intervention: KAP consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.

Outcomes: Self-reported measures of symptoms of depression, anxiety, and post traumatic stress at 1, 3, and 6 months.

Statistical Analysis: Analyses were by intention to treat. Main analysis was a mixed linear model or growth curve model to estimate change over time per outcome, yielding estimates of mean changes at each endpoint relative to baseline. Secondary analyses included evaluating case reductions (identified by cut-off values) and minimal clinically important differences (MCIDs) at each endpoint relative to baseline.

Significance: This study may provide evidence of sustained real-world effects of Ketamine-Assisted Psychotherapy, of interest to patients, clinicians, researchers, and policymakers.

• Study Type: Interventional
• Enrollment (Actual): 1806
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6J 5B3
      • Vancouver Centre
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 7E6
      • Fredericton Centre
  • Ontario
    • Toronto, Ontario, Canada, M5V 2C3
      • Field Trip Health, Toronto Centre
• United States
  • California
    • Los Angeles, California, United States, 90404
      • LA Centre
    • San Diego, California, United States, 92037
      • San Diego Centre
  • District of Columbia
    • Washington, District of Columbia, United States, 20005
      • Washington DC Centre
  • Georgia
    • Atlanta, Georgia, United States, 30316
      • Atlanta Centre
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Centre
  • New York
    • New York, New York, United States, 10010
      • NYC Centre
  • Texas
    • Houston, Texas, United States, 77027
      • Houston Centre
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clients; Adult patients coping with symptoms of depression, anxiety, and post traumatic stress	Combination product: Ketamine-Assisted Psychotherapy (KAP); KAP consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
9-item Patient Health Questionnaire (PHQ-9)	Self-reported measure of depression, ranging from 0-27. Higher scores are worse.	Change from 3 months compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)	Self-reported measure of anxiety, ranging from 0-21. Higher scores are worse.	Change from 3 months compared to baseline
6-item PTSD Checklist (PCL-6)	Self-reported measure of post traumatic stress, ranging from 6-30. Higher scores are worse.	Change from 3 months compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
9-item Patient Health Questionnaire (PHQ-9)	Self-reported measure of depression, ranging from 0-27.	Change from 1 month compared to baseline
9-item Patient Health Questionnaire (PHQ-9)	Self-reported measure of depression, ranging from 0-27.	Change from 6 months compared to baseline
6-item PTSD Checklist (PCL-6)	Self-reported measure of post traumatic stress, ranging from 6-30.	Change from 1 month compared to baseline
6-item PTSD Checklist (PCL-6)	Self-reported measure of post traumatic stress, ranging from 6-30.	Change from 6 months compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)	Self-reported measure of anxiety, ranging from 0-21.	Change from 1 month compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)	Self-reported measure of anxiety, ranging from 0-21.	Change from 6 months compared to baseline

Collaborators and Investigators

• Sponsor: Field Trip Health
• Investigators: Principal Investigator: Ryan Yermus, MD, Field Trip Health; Principal Investigator: Chris Lo, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 30, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mental health; ketamine; psychotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 2022-3067-11240-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No