DepressionPhase 4NCT05604794
A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health
A Phase 4 study testing Ketamine-Assisted Psychotherapy (KAP) in people with Depression and Anxiety, run by Field Trip Health at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression, Anxiety, Post Traumatic Stress Disorder
- What is being tested?
- Ketamine-Assisted Psychotherapy (KAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,806 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 13 Mar 2020to 16 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
Atlanta Centre
Atlanta, Georgia, 30316
Chicago Centre
Chicago, Illinois, 60654
Houston Centre
Houston, Texas, 77027
LA Centre
Los Angeles, California, 90404
NYC Centre
New York, New York, 10010
San Diego Centre
San Diego, California, 92037
Seattle Centre
Seattle, Washington, 98109
Washington DC Centre
Washington D.C., District of Columbia, 20005
Canada3 sites
Fredericton Centre
Fredericton, New Brunswick, E3B 7E6
Field Trip Health, Toronto Centre
Toronto, Ontario, M5V 2C3
Vancouver Centre
Vancouver, British Columbia, V6J 5B3
About this study
Official title: 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.
Read the 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
- Being tested
- Ketamine-Assisted Psychotherapy (KAP)
- Keywords
- ketamine, psychotherapy, mental health
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Clients | Experimental | Adult patients coping with symptoms of depression, anxiety, and post traumatic stress Receives: Combination Product: Ketamine-Assisted Psychotherapy (KAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27. Higher scores are worse.
Measured: 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.
Measured: 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.
Measured: Change from 3 months compared to baseline
Secondary outcomes (6)
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27.
Measured: Change from 1 month compared to baseline
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27.
Measured: Change from 6 months compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21.
Measured: Change from 1 month compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21.
Measured: Change from 6 months compared to baseline
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30.
Measured: Change from 1 month compared to baseline
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30.
Measured: Change from 6 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start13 Mar 2020
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,806 participants (actual)
Sponsor and investigators
- Lead sponsor
- Field Trip Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Yermus, MD, Principal investigator, Field Trip HealthChris Lo, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604794
- Sponsor's protocol ID
- 2022-3067-11240-5
- Status last verified
- Feb 2024
- First submitted
- 12 Oct 2022
- Last updated
- 20 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Ketamine Assisted Psychotherapy Program on Mental Health at Field Trip Health Centres in North America
- ClinicalTrials.gov ID
- NCT05604794
- Acronym / sponsor ID
- 2022-3067-11240-5
- Conditions
- Depression, Anxiety, Post Traumatic Stress Disorder
- Keywords
- ketamine, psychotherapy, mental health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,806 participants (actual)
- Lead sponsor
- Field Trip HealthIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Posted 12 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clients | Experimental | Combination Product: Ketamine-Assisted Psychotherapy (KAP)Adult patients coping with symptoms of depression, anxiety, and post traumatic stress |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Clients |
Primary outcome
9-item Patient Health Questionnaire (PHQ-9)
Time frame: Change from 3 months compared to baseline
Self-reported measure of depression, ranging from 0-27. Higher scores are worse.
7-item Generalized Anxiety Disorder Measure (GAD-7)
Time frame: Change from 3 months compared to baseline
Self-reported measure of anxiety, ranging from 0-21. Higher scores are worse.
6-item PTSD Checklist (PCL-6)
Time frame: Change from 3 months compared to baseline
Self-reported measure of post traumatic stress, ranging from 6-30. Higher scores are worse.
6 secondary outcomes
9-item Patient Health Questionnaire (PHQ-9)
Time frame: Change from 1 month compared to baseline
9-item Patient Health Questionnaire (PHQ-9)
Time frame: Change from 6 months compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)
Time frame: Change from 1 month compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)
Time frame: Change from 6 months compared to baseline
6-item PTSD Checklist (PCL-6)
Time frame: Change from 1 month compared to baseline
6-item PTSD Checklist (PCL-6)
Time frame: Change from 6 months compared to baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Yermus, MD principal investigator
Field Trip Health
Chris Lo, PhD principal investigator
University of Toronto
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine-Assisted Psychotherapy (KAP) in people with Depression and Anxiety, run by Field Trip Health at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
9-item Patient Health Questionnaire (PHQ-9) (time frame: Change from 3 months compared to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.