A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health
Condition: Depression; Anxiety; Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: 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.
Intervention MeSH terms: Ketamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1806.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: ketamine; psychotherapy; mental health

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.
    

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