Trial Outcomes & Findings for Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers (NCT NCT06001372)
NCT ID: NCT06001372
Last Updated: 2025-04-16
Results Overview
To assess the feasibility of completion of the study intervention. This outcome measure will report the number of participants who reached study completion. Study completion was defined as participating in at least 2/3 of the 3 KAP sessions.
Recruitment status
TERMINATED
Study phase
EARLY_PHASE1
Target enrollment
2 participants
Primary outcome timeframe
Up to 3 KAP sessions (2 weeks from the initiation of study treatment)
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
Arm 1
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Ketamine: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
* Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
* Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
* Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers
Baseline characteristics by cohort
| Measure |
Arm 1
n=2 Participants
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Ketamine: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
* Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
* Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
* Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 15.56 • n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 3 KAP sessions (2 weeks from the initiation of study treatment)To assess the feasibility of completion of the study intervention. This outcome measure will report the number of participants who reached study completion. Study completion was defined as participating in at least 2/3 of the 3 KAP sessions.
Outcome measures
| Measure |
Arm 1
n=2 Participants
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Ketamine: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
* Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
* Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
* Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
|
|---|---|
|
The Rate of Study Completion by Enrolled Participants. Study Completion is Defined as Participating in at Least 2 of the 3 Ketamine-Assisted Psychotherapy (KAP) Sessions.
Number of subjects who reached study completion.
|
2 Participants
|
|
The Rate of Study Completion by Enrolled Participants. Study Completion is Defined as Participating in at Least 2 of the 3 Ketamine-Assisted Psychotherapy (KAP) Sessions.
Number of subjects who did not reach study completion.
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 48 days after initiation of the study treatment (30 days after the last dose of study treatment)This outcome will report the count of AEs and SAEs characterized by severity (as defined by the NIH CTCAE, version 5.0) to assess the safety and tolerability of ketamine-assisted therapy in the study population. All subjects who receive any study treatment will be included in the final summaries and listings of safety data. The severity of the AEs was graded according to the CTCAE v5.0. The CTCAE uses a 5-point grading system to assess the severity of AEs: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe * Grade 4: Life-threatening * Grade 5: Death This outcome measure will report the count of participants who experienced an AE or SAE at each toxicity grade. Adverse events were followed until 14 days after the last dose of study treatment.
Outcome measures
| Measure |
Arm 1
n=2 Participants
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Ketamine: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
* Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
* Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
* Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
|
|---|---|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 1 · Yes
|
1 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 1 · No
|
1 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 2 · Yes
|
1 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 2 · No
|
1 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 3 · Yes
|
0 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 3 · No
|
2 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 4 · Yes
|
0 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 4 · No
|
2 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 5 · Yes
|
0 Participants
|
|
The Severity of Adverse Events (AEs)
Toxicity Grade 5 · No
|
2 Participants
|
SECONDARY outcome
Timeframe: Ketamine Session 1 (up to 1 day), Ketamine Session 2 (up to 7 days), Ketamine Session 3 (up to 15 days), Follow-Up Day 14 (up to 29 days), Follow-Up Day 30 (up to 48 days), and Follow-Up Day 90 (up to 100 days).This outcome will report the proportion of screened patients that meet Existential Distress Scale (EDS) criteria (Single domain score ≥ 3 or Total score ≥ 6). EDS is a 10-item questionnaire for subjects to rank questions about distressing thoughts from 0 to 4 (0 as not distressed, 4 as unbearably distressed). A higher score represents a higher level of Existential Distress. This outcome will report the count of subjects meeting EDS criteria at the following visits Ketamine Session 1, Ketamine Session 2, Ketamine Session 3, Follow-Up Day 14, Follow-Up Day 30, and Follow-Up Day 90.
Outcome measures
| Measure |
Arm 1
n=2 Participants
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Ketamine: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
* Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
* Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
* Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
|
|---|---|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 3 · Not Assessed
|
1 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 30 · Criteria (Single domain ≥ 3 or total score ≥ 6)
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 1 · Criteria (Single domain ≥ 3 or total score ≥ 6)
|
2 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 1 · Not Meeting Criteria (Single domain < 3 or total score < 6)
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 1 · Not Assessed
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 2 · Criteria (Single domain ≥ 3 or total score ≥ 6)
|
2 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 2 · Not Meeting Criteria (Single domain < 3 or total score < 6)
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 2 · Not Assessed
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 3 · Criteria (Single domain ≥ 3 or total score ≥ 6)
|
1 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Ketamine Session 3 · Not Meeting Criteria (Single domain < 3 or total score < 6)
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 14 · Criteria (Single domain ≥ 3 or total score ≥ 6)
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 14 · Not Meeting Criteria (Single domain < 3 or total score < 6)
|
1 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 14 · Not Assessed
|
1 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 30 · Not Meeting Criteria (Single domain < 3 or total score < 6)
|
1 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 30 · Not Assessed
|
1 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 90 · Criteria (Single domain ≥ 3 or total score ≥ 6)
|
0 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 90 · Not Meeting Criteria (Single domain < 3 or total score < 6)
|
1 Participants
|
|
To Determine the Prevalence of Existential Distress in Patients With Non-operable GI Cancers.
Follow-Up Day 90 · Not Assessed
|
1 Participants
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=2 participants at risk
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Ketamine: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
* Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
* Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
* Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
|
|---|---|
|
Psychiatric disorders
Suicidal ideation
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were recorded from consent until 30 days after the last dose of study medication or until new cancer therapy was started, up to 48 days after initiation of study treatment.
|
Other adverse events
| Measure |
Arm 1
n=2 participants at risk
Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
Ketamine: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
* Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
* Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
* Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
|
|---|---|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • AEs and SAEs were recorded from consent until 30 days after the last dose of study medication or until new cancer therapy was started, up to 48 days after initiation of study treatment.
|
Additional Information
IIT Data Management Team
Research Compliance Office, Huntsman Cancer Institute
Phone: 801-213-6215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place