Clinical TrialDepressive DisordersKetamineCompleted

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

Retrospective, single-group effectiveness study (n=1806) assessing Ketamine‑Assisted Psychotherapy (4–6 ketamine sessions plus psychotherapy) for depression, anxiety, and PTSD with follow-up to 6 months.

Target Enrollment
1806 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Retrospective single-group effectiveness trial of KAP delivered across 11 Field Trip Health clinics in North America; intervention comprised 4–6 guided ketamine sessions paired with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.

Outcomes were self-reported symptoms of depression, anxiety and post-traumatic stress at 1, 3 and 6 months; analyses used mixed linear models to estimate change from baseline (intention-to-treat), with secondary analyses of case reductions and minimal clinically important differences.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

KAP

experimental

Combination ketamine plus psychotherapy delivered as a package (Field Trip Health KAP).

Interventions

  • Ketamine
    • 4-6 sessions• 6 doses total

    KAP consisting of 4–6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses; pragmatic, single-group.

Participants

Ages
19 – 99
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Completed
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment1806 participants
  • Timeline
    Start: 2020-03-13
    End: 2022-06-16
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

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

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