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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05604794
Other study ID # 2022-3067-11240-5
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 13, 2020
Est. completion date June 16, 2022

Study information

Verified date February 2024
Source Field Trip Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1806
Est. completion date June 16, 2022
Est. primary completion date June 16, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design


Intervention

Combination Product:
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.

Locations

Country Name City State
Canada Fredericton Centre Fredericton New Brunswick
Canada Field Trip Health, Toronto Centre Toronto Ontario
Canada Vancouver Centre Vancouver British Columbia
United States Atlanta Centre Atlanta Georgia
United States Chicago Centre Chicago Illinois
United States Houston Centre Houston Texas
United States LA Centre Los Angeles California
United States NYC Centre New York New York
United States San Diego Centre San Diego California
United States Seattle Centre Seattle Washington
United States Washington DC Centre Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Field Trip Health

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 9-item Patient Health Questionnaire (PHQ-9) Self-reported measure of depression, ranging from 0-27. Change from 1 month compared to baseline
Secondary 9-item Patient Health Questionnaire (PHQ-9) Self-reported measure of depression, ranging from 0-27. Change from 6 months compared to baseline
Secondary 7-item Generalized Anxiety Disorder Measure (GAD-7) Self-reported measure of anxiety, ranging from 0-21. Change from 1 month compared to baseline
Secondary 7-item Generalized Anxiety Disorder Measure (GAD-7) Self-reported measure of anxiety, ranging from 0-21. Change from 6 months compared to baseline
Secondary 6-item PTSD Checklist (PCL-6) Self-reported measure of post traumatic stress, ranging from 6-30. Change from 1 month compared to baseline
Secondary 6-item PTSD Checklist (PCL-6) Self-reported measure of post traumatic stress, ranging from 6-30. Change from 6 months compared to baseline
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