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

NCT05604794 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2022-3067-11240-5
• Study Type: interventional
• Target: 1,806
• Locations: 2 countries
• Sites: 11

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.

Conditions

Depression; Anxiety; Post Traumatic Stress Disorder

Keywords

ketamine; psychotherapy; mental health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

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

  Change from 1 month compared to baseline

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

  Change from 6 months compared to baseline

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

  Change from 1 month compared to baseline

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

  Change from 6 months compared to baseline

• 6-item PTSD Checklist (PCL-6)

  Change from 1 month compared to baseline

Study Arms (1)

Clients

EXPERIMENTAL

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

Combination Product: Ketamine-Assisted Psychotherapy (KAP)

Interventions

Ketamine-Assisted Psychotherapy (KAP) 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.

Clients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Field Trip Health: lead

Study Sites (11)

LA Centre

Los Angeles, California, 90404, United States

Location

San Diego Centre

San Diego, California, 92037, United States

Location

Washington DC Centre

Washington D.C., District of Columbia, 20005, United States

Location

Atlanta Centre

Atlanta, Georgia, 30316, United States

Location

Chicago Centre

Chicago, Illinois, 60654, United States

Location

NYC Centre

New York, New York, 10010, United States

Location

Houston Centre

Houston, Texas, 77027, United States

Location

Seattle Centre

Seattle, Washington, 98109, United States

Location

Vancouver Centre

Vancouver, British Columbia, V6J 5B3, Canada

Location

Fredericton Centre

Fredericton, New Brunswick, E3B 7E6, Canada

Location

Field Trip Health, Toronto Centre

Toronto, Ontario, M5V 2C3, Canada

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personal Satisfaction

Limitations and Caveats

Based on feedback from the peer review process, this study should be considered a cohort study rather than a trial. The high attrition rate may limit validity of results.

Results Point of Contact

• Title: Dr Chris Lo
• Organization: University of Toronto

chris.lo@utoronto.ca

65 6709 3003

Study Officials

• Ryan Yermus, MD

  Field Trip Health

  PRINCIPAL INVESTIGATOR

• Chris Lo, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 3, 2022
• Study Start: March 13, 2020
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: March 20, 2024
• Results First Posted: May 12, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); CA (3)