NCT05604794 is a Phase 4 clinical trial of Ketamine-Assisted Psychotherapy (KAP) in Depression, sponsored by Field Trip Health.

Who is sponsoring NCT05604794?

NCT05604794 is sponsored by Field Trip Health.

What drugs are being tested in NCT05604794?

Interventions in NCT05604794: Ketamine-Assisted Psychotherapy (KAP).

What condition does NCT05604794 study?

NCT05604794 studies Depression, Anxiety, Post Traumatic Stress Disorder.

Is NCT05604794 still recruiting?

NCT05604794 is currently completed. Last updated 20 March 2024.

Are results published for NCT05604794?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-20 · How we verify

NCT05604794

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 20 March 2024

What this trial tests

Phase 4 trial testing Ketamine-Assisted Psychotherapy (KAP) in Depression in 1,806 participants. Completed in 16 June 2022.

Timeline

13 March 2020

Primary endpoint
16 June 2022

16 June 2022

Quick facts

Lead sponsor	Field Trip Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1,806
Start date	13 March 2020
Primary completion	16 June 2022
Estimated completion	16 June 2022
Sites	11 locations across Canada, United States

Drugs / interventions tested

Ketamine-Assisted Psychotherapy (KAP)

Conditions studied

Depression — all drugs for Depression →
Anxiety — all drugs for Anxiety →
Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

Field Trip Health

Who can join

19 and older, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

9-item Patient Health Questionnaire (PHQ-9) Primary · Change from 3 months compared to baseline

Self-reported measure of depression, ranging from 0-27. Higher scores are worse.

Group	Value	95% CI
Clients	-3.23	-3.57 – -2.90

7-item Generalized Anxiety Disorder Measure (GAD-7) Primary · Change from 3 months compared to baseline

Self-reported measure of anxiety, ranging from 0-21. Higher scores are worse.

Group	Value	95% CI
Clients	-4.80	-5.17 – -4.44

6-item PTSD Checklist (PCL-6) Primary · Change from 3 months compared to baseline

Self-reported measure of post traumatic stress, ranging from 6-30. Higher scores are worse.

Group	Value	95% CI
Clients	-4.24	-4.60 – -3.87

9-item Patient Health Questionnaire (PHQ-9) Secondary · Change from 1 month compared to baseline

Self-reported measure of depression, ranging from 0-27.

Group	Value	95% CI
Clients	-3.23	-3.57 – -2.90

9-item Patient Health Questionnaire (PHQ-9) Secondary · Change from 6 months compared to baseline

Self-reported measure of depression, ranging from 0-27.

Group	Value	95% CI
Clients	-4.74	-5.68 – -3.80

7-item Generalized Anxiety Disorder Measure (GAD-7) Secondary · Change from 1 month compared to baseline

Self-reported measure of anxiety, ranging from 0-21.

Group	Value	95% CI
Clients	-2.65	-2.95 – -2.34

7-item Generalized Anxiety Disorder Measure (GAD-7) Secondary · Change from 6 months compared to baseline

Self-reported measure of anxiety, ranging from 0-21.

Group	Value	95% CI
Clients	-4.10	-5.02 – -3.18

6-item PTSD Checklist (PCL-6) Secondary · Change from 1 month compared to baseline

Self-reported measure of post traumatic stress, ranging from 6-30.

Group	Value	95% CI
Clients	-2.14	-2.44 – -1.83

6-item PTSD Checklist (PCL-6) Secondary · Change from 6 months compared to baseline

Self-reported measure of post traumatic stress, ranging from 6-30.

Group	Value	95% CI
Clients	-3.44	-4.38 – -2.50

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Ketamine-assisted psychotherapy provides lasting and effective results in the treatment of depression, anxiety and post traumatic stress disorder at 3 and 6 months: Findings from a large single-arm retrospective effectiveness trial
Yermus R, Verbora M, Kennedy S, McMaster R, et al · · 2023 · DOI 10.1101/2023.01.11.23284248

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05604794 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Field Trip Health
Last refreshed: 20 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05604794.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing