CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,806 enrolled
Drug / intervention
Ketamine-Assisted Psychotherapy (KAP)combination
Likely dose
Ketamine-assisted psychotherapy consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent dosesAI-extracted
Key inclusion· 6
  • Over 18 years old
  • Diagnosed with Major Depressive Disorder, Bipolar Depression, Generalized Anxiety Disorder, OCD, or Eating Disorder by a licensed healthcare practitioner
  • Significant history of trauma and/or formal diagnosis of PTSD per DSM 5
  • Psychologically and medically cleared by psychiatrist, family physician, or treatment team
Key exclusion· 11
  • Unable to consent to treatment
  • Pregnant women and nursing mothers (postpartum depression considered case-by-case)
  • Substance Use Disorder meeting DSM 5 criteria in past 3 months; alcohol/opioid/benzodiazepine/cocaine/amphetamine use disorders require detox and 4-week sobriety
  • Daily use of moderate to high doses of benzodiazepines

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05604794
NCT05604794Phase 4Completed

Retrospective Review of Ketamine Assisted Psychotherapy Program on Mental Health at Field Trip Health Centres in North America

Field Trip Health·interventional·Posted Nov 3, 2022·Updated Mar 20, 2024

In Brief

A Phase 4 clinical trial evaluating Ketamine-Assisted Psychotherapy (KAP) for Depression and 2 related conditions. Completed, enrolled 1,806 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedNov 3, 2022
Enrollment StartMar 13, 2020
Primary CompletionJun 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 3.7 years ago

Interventions

Ketamine-Assisted Psychotherapy (KAP)combination

KAP consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.