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

NCT ID: NCT05604794

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1806 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-13
• Study Completion Date: 2022-06-16

Brief 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.

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.

Conditions

Depression; Anxiety; Post Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clients

Adult patients coping with symptoms of depression, anxiety, and post traumatic stress

Group Type: EXPERIMENTAL

Ketamine-Assisted Psychotherapy (KAP)

Intervention Type: COMBINATION_PRODUCT

KAP consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Field Trip Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Yermus, MD

Role: PRINCIPAL_INVESTIGATOR

Field Trip Health

Chris Lo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

LA Centre

Los Angeles, California, United States

San Diego Centre

San Diego, California, United States

Washington DC Centre

Washington D.C., District of Columbia, United States

Atlanta Centre

Atlanta, Georgia, United States

Chicago Centre

Chicago, Illinois, United States

NYC Centre

New York, New York, United States

Houston Centre

Houston, Texas, United States

Seattle Centre

Seattle, Washington, United States

Vancouver Centre

Vancouver, British Columbia, Canada

Fredericton Centre

Fredericton, New Brunswick, Canada

Field Trip Health, Toronto Centre

Toronto, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-3067-11240-5

Identifier Type: -

Identifier Source: org_study_id