Clinical trial NCT05604794: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Anxiety
Post Traumatic Stress Disorder
Keywords: ketamine
psychotherapy
mental health
Lead sponsor: Field Trip Health
Sponsor class: INDUSTRY
First posted: 2022-11-03
Enrollment: 1806
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Change from 3 months compared to baseline
measure: 7-item Generalized Anxiety Disorder Measure (GAD-7)
timeFrame: Change from 3 months compared to baseline
measure: 6-item PTSD Checklist (PCL-6)
timeFrame: Change from 3 months compared to baseline
Secondary outcomes:
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Change from 1 month compared to baseline
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Change from 6 months compared to baseline
measure: 7-item Generalized Anxiety Disorder Measure (GAD-7)
timeFrame: Change from 1 month compared to baseline
measure: 7-item Generalized Anxiety Disorder Measure (GAD-7)
timeFrame: Change from 6 months compared to baseline
measure: 6-item PTSD Checklist (PCL-6)
timeFrame: Change from 1 month compared to baseline
measure: 6-item PTSD Checklist (PCL-6)
timeFrame: Change from 6 months compared to baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA Centre
state: California
city: San Diego
country: United States
facility: San Diego Centre
state: California
city: Washington
country: United States
facility: Washington DC Centre
state: District of Columbia
city: Atlanta
country: United States
facility: Atlanta Centre
state: Georgia
city: Chicago
country: United States
facility: Chicago Centre
state: Illinois
city: New York
country: United States
facility: NYC Centre
state: New York
city: Houston
country: United States
facility: Houston Centre
state: Texas
city: Seattle
country: United States
facility: Seattle Centre
state: Washington
city: Vancouver
country: Canada
facility: Vancouver Centre
state: British Columbia
city: Fredericton
country: Canada
facility: Fredericton Centre
state: New Brunswick
city: Toronto
country: Canada
facility: Field Trip Health, Toronto Centre
state: Ontario
Study officials:
affiliation: Field Trip Health
name: Ryan Yermus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Chris Lo, PhD
role: PRINCIPAL_INVESTIGATOR
References: