Trial Outcomes & Findings for A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health (NCT NCT05604794)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1806 participants

Primary outcome timeframe

Change from 3 months compared to baseline

Results posted on

2024-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Clients Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
Overall Study STARTED	1806
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	1712

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clients n=1806 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
Age, Continuous	42 years STANDARD_DEVIATION 12 • n=5 Participants
Sex/Gender, Customized Gender · Female	948 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	850 Participants n=5 Participants
Sex/Gender, Customized Gender · Non-binary	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	1309 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other Groups	441 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Missing	56 Participants n=5 Participants
Region of Enrollment North America	1806 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from 3 months compared to baseline

Population: Number analysed after attrition.

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

Outcome measures

Outcome measures
Measure	Clients n=315 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
9-item Patient Health Questionnaire (PHQ-9)	-3.23 units on a scale Interval -3.57 to -2.9

PRIMARY outcome

Timeframe: Change from 3 months compared to baseline

Population: Number analysed after attrition.

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

Outcome measures

Outcome measures
Measure	Clients n=305 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
7-item Generalized Anxiety Disorder Measure (GAD-7)	-4.80 units on a scale Interval -5.17 to -4.44

PRIMARY outcome

Timeframe: Change from 3 months compared to baseline

Population: Number analysed after attrition.

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

Outcome measures

Outcome measures
Measure	Clients n=299 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
6-item PTSD Checklist (PCL-6)	-4.24 units on a scale Interval -4.6 to -3.87

SECONDARY outcome

Timeframe: Change from 1 month compared to baseline

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

Outcome measures

Outcome measures
Measure	Clients n=330 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
9-item Patient Health Questionnaire (PHQ-9)	-3.23 units on a scale Interval -3.57 to -2.9

SECONDARY outcome

Timeframe: Change from 6 months compared to baseline

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

Outcome measures

Outcome measures
Measure	Clients n=92 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
9-item Patient Health Questionnaire (PHQ-9)	-4.74 units on a scale Interval -5.68 to -3.8

SECONDARY outcome

Timeframe: Change from 1 month compared to baseline

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

Outcome measures

Outcome measures
Measure	Clients n=333 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
7-item Generalized Anxiety Disorder Measure (GAD-7)	-2.65 units on a scale Interval -2.95 to -2.34

SECONDARY outcome

Timeframe: Change from 6 months compared to baseline

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

Outcome measures

Outcome measures
Measure	Clients n=72 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
7-item Generalized Anxiety Disorder Measure (GAD-7)	-4.10 units on a scale Interval -5.02 to -3.18

SECONDARY outcome

Timeframe: Change from 1 month compared to baseline

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

Outcome measures

Outcome measures
Measure	Clients n=327 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
6-item PTSD Checklist (PCL-6)	-2.14 units on a scale Interval -2.44 to -1.83

SECONDARY outcome

Timeframe: Change from 6 months compared to baseline

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

Outcome measures

Outcome measures
Measure	Clients n=69 Participants Adult patients coping with symptoms of depression, anxiety, and post traumatic stress 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.
6-item PTSD Checklist (PCL-6)	-3.44 units on a scale Interval -4.38 to -2.5

Adverse Events

Clients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Chris Lo

University of Toronto

Phone: 65 6709 3003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
Publication restrictions are in place

Restriction type: OTHER