Trial Outcomes & Findings for Psychopharmacology of Psilocybin in Cancer Patients (NCT NCT00465595)
NCT ID: NCT00465595
Last Updated: 2018-07-19
Results Overview
The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Baseline, 5 weeks post session 1 and 2, 6-month follow-up
Results posted on
2018-07-19
Participant Flow
Participants were recruited through flyers, internet, and physician referral.
Participant milestones
| Measure |
Low-Dose First
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
High-Dose First
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychopharmacology of Psilocybin in Cancer Patients
Baseline characteristics by cohort
| Measure |
Low-Dose First
n=25 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
High-Dose First
n=26 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
56.5 years
STANDARD_DEVIATION 9.18 • n=4 Participants
|
56.3 years
STANDARD_DEVIATION 9.99 • n=27 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Education
High School
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Education
College
|
8 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Education
Post-graduate
|
16 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 5 weeks post session 1 and 2, 6-month follow-upThe GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD
Outcome measures
| Measure |
Low-Dose First Baseline
n=25 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
Low-Dose First Post Session 1
n=25 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
Low-Dose First Post Session 2
n=24 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
Low-Dose First 6 Month
n=22 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
High-Dose First Baseline
n=26 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
High-Dose First Post Session 1
n=25 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
High-Dose First Post Session 2
n=25 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
High-Dose First 6 Month
n=24 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
|---|---|---|---|---|---|---|---|---|
|
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.
|
22.32 units on a scale
Standard Error .88
|
14.8 units on a scale
Standard Error 1.45
|
6.5 units on a scale
Standard Error .86
|
6.95 units on a scale
Standard Error 1.24
|
22.84 units on a scale
Standard Error .97
|
6.64 units on a scale
Standard Error 1.04
|
6.52 units on a scale
Standard Error 1.44
|
6.23 units on a scale
Standard Error 1.3
|
PRIMARY outcome
Timeframe: Baseline, 5 weeks post session 1 and 2, 6-month follow-upThe Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A
Outcome measures
| Measure |
Low-Dose First Baseline
n=25 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
Low-Dose First Post Session 1
n=25 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
Low-Dose First Post Session 2
n=24 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
Low-Dose First 6 Month
n=22 Participants
The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session.
|
High-Dose First Baseline
n=26 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
High-Dose First Post Session 1
n=25 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
High-Dose First Post Session 2
n=25 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
High-Dose First 6 Month
n=24 Participants
The High-Dose-1st Group received the high dose on the first session and the low dose on the second session.
|
|---|---|---|---|---|---|---|---|---|
|
HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).
|
25.68 units on a scale
Standard Error .89
|
16.64 units on a scale
Standard Error 1.53
|
8.92 units on a scale
Standard Error 1.14
|
7.95 units on a scale
Standard Error 1.19
|
25.73 units on a scale
Standard Error 1.11
|
8.48 units on a scale
Standard Error 1.16
|
7.52 units on a scale
Standard Error 1.27
|
7.04 units on a scale
Standard Error 1.17
|
Adverse Events
Low Dose Condition (Group)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
High Dose Condition (Group)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Condition (Group)
n=56 participants at risk
The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The Low Dose Group is comprised of all low dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts.
|
High Dose Condition (Group)
n=56 participants at risk
The experimental design of this study is a complete cross-over, with two groups of participants receiving the low and high doses of psilocybin in counterbalance order. The High Dose Group is comprised of all high dose psilocybin sessions (n=50). The number of sessions is different from the total enrollment because of dropouts.
|
|---|---|---|
|
Cardiac disorders
Elevated Systolic Blood Pressure
|
16.1%
9/56
|
28.6%
16/56
|
|
Cardiac disorders
Elevated Diastolic Blood Pressure
|
1.8%
1/56
|
12.5%
7/56
|
|
General disorders
Nausea
|
0.00%
0/56
|
12.5%
7/56
|
|
Psychiatric disorders
Anxiety Episode
|
12.5%
7/56
|
23.2%
13/56
|
Additional Information
Roland R. Griffiths, Ph.D., Principal Investigator
Johns Hopkins University School of Medicine
Phone: 4105500034
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place