Back to resultsA Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health
Primary Purpose
Depression, Anxiety, Post Traumatic Stress Disorder
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ketamine-Assisted Psychotherapy (KAP)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring ketamine, psychotherapy, mental health
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
Sites / Locations
- LA Centre
- San Diego Centre
- Washington DC Centre
- Atlanta Centre
- Chicago Centre
- NYC Centre
- Houston Centre
- Seattle Centre
- Vancouver Centre
- Fredericton Centre
- Field Trip Health, Toronto Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Clients
Arm Description
Adult patients coping with symptoms of depression, anxiety, and post traumatic stress
Outcomes
Primary Outcome Measures
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27. Higher scores are worse.
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21. Higher scores are worse.
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30. Higher scores are worse.
Secondary Outcome Measures
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27.
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27.
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21.
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21.
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30.
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05604794
Brief Title
A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health
Official Title
Retrospective Review of Ketamine Assisted Psychotherapy Program on Mental Health at Field Trip Health Centres in North America
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Field Trip Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Post Traumatic Stress Disorder
Keywords
ketamine, psychotherapy, mental health
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1806 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clients
Arm Type
Experimental
Arm Description
Adult patients coping with symptoms of depression, anxiety, and post traumatic stress
Intervention Type
Combination Product
Intervention Name(s)
Ketamine-Assisted Psychotherapy (KAP)
Intervention Description
KAP consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.
Primary Outcome Measure Information:
Title
9-item Patient Health Questionnaire (PHQ-9)
Description
Self-reported measure of depression, ranging from 0-27. Higher scores are worse.
Time Frame
Change from 3 months compared to baseline
Title
7-item Generalized Anxiety Disorder Measure (GAD-7)
Description
Self-reported measure of anxiety, ranging from 0-21. Higher scores are worse.
Time Frame
Change from 3 months compared to baseline
Title
6-item PTSD Checklist (PCL-6)
Description
Self-reported measure of post traumatic stress, ranging from 6-30. Higher scores are worse.
Time Frame
Change from 3 months compared to baseline
Secondary Outcome Measure Information:
Title
9-item Patient Health Questionnaire (PHQ-9)
Description
Self-reported measure of depression, ranging from 0-27.
Time Frame
Change from 1 month compared to baseline
Title
9-item Patient Health Questionnaire (PHQ-9)
Description
Self-reported measure of depression, ranging from 0-27.
Time Frame
Change from 6 months compared to baseline
Title
7-item Generalized Anxiety Disorder Measure (GAD-7)
Description
Self-reported measure of anxiety, ranging from 0-21.
Time Frame
Change from 1 month compared to baseline
Title
7-item Generalized Anxiety Disorder Measure (GAD-7)
Description
Self-reported measure of anxiety, ranging from 0-21.
Time Frame
Change from 6 months compared to baseline
Title
6-item PTSD Checklist (PCL-6)
Description
Self-reported measure of post traumatic stress, ranging from 6-30.
Time Frame
Change from 1 month compared to baseline
Title
6-item PTSD Checklist (PCL-6)
Description
Self-reported measure of post traumatic stress, ranging from 6-30.
Time Frame
Change from 6 months compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Yermus, MD
Organizational Affiliation
Field Trip Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Lo, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
LA Centre
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
San Diego Centre
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Washington DC Centre
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Facility Name
Atlanta Centre
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30316
Country
United States
Facility Name
Chicago Centre
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
NYC Centre
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Houston Centre
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Seattle Centre
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6J 5B3
Country
Canada
Facility Name
Fredericton Centre
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 7E6
Country
Canada
Facility Name
Field Trip Health, Toronto Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 2C3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health
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