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Trial · NCT00465595

Psychopharmacology of Psilocybin in Cancer Patients

NCT00465595, Phase 2, Completed, Johns Hopkins University; results first posted 2018-07-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Psychopharmacology of Psilocybin in Cancer Patients. Trials, record NCT00465595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00465595

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Psychopharmacology of Psilocybin in Cancer Patients
NCT number
NCT00465595
Status
Completed
Phases
Phase 2
Enrollment
56 participants, actual
Lead sponsor
Johns Hopkins University
Conditions
Depressive Symptoms, Anxiety, Cancer
Interventions
psilocybin
First posted
2007-04-25
Last updated
2018-07-19
Results first posted
2018-07-19

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryGRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.Baseline, 5 weeks post session 1 and 2, 6-month follow-up
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
PrimaryHAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).Baseline, 5 weeks post session 1 and 2, 6-month follow-up
The 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

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYGRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.Baseline, 5 weeks post session 1 and 2, 6-month follow-upunits on a scaleMEAN
PRIMARYHAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).Baseline, 5 weeks post session 1 and 2, 6-month follow-upunits on a scaleMEAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.Low-Dose First Baseline22.32Standard Error .88units on a scale
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.Low-Dose First Post Session 114.8Standard Error 1.45units on a scale
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.Low-Dose First Post Session 26.5Standard Error .86units on a scale
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.Low-Dose First 6 Month6.95Standard Error 1.24units on a scale
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.High-Dose First Baseline22.84Standard Error .97units on a scale
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.High-Dose First Post Session 16.64Standard Error 1.04units on a scale
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.High-Dose First Post Session 26.52Standard Error 1.44units on a scale
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.High-Dose First 6 Month6.23Standard Error 1.3units on a scale
HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).Low-Dose First Baseline25.68Standard Error .89units on a scale
HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).Low-Dose First Post Session 116.64Standard Error 1.53units on a scale

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDLow-Dose First27
Overall StudySTARTEDHigh-Dose First29
Overall StudyCOMPLETEDLow-Dose First22
Overall StudyCOMPLETEDHigh-Dose First24
Overall StudyNOT COMPLETEDLow-Dose First5
Overall StudyNOT COMPLETEDHigh-Dose First5

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherElevated Systolic Blood PressureCardiac disordersLow Dose Condition (Group)956
otherElevated Systolic Blood PressureCardiac disordersHigh Dose Condition (Group)1656
otherElevated Diastolic Blood PressureCardiac disordersLow Dose Condition (Group)156
otherElevated Diastolic Blood PressureCardiac disordersHigh Dose Condition (Group)756
otherNauseaGeneral disordersLow Dose Condition (Group)056
otherNauseaGeneral disordersHigh Dose Condition (Group)756
otherAnxiety EpisodePsychiatric disordersLow Dose Condition (Group)756
otherAnxiety EpisodePsychiatric disordersHigh Dose Condition (Group)1356

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityLow Dose Condition (Group)
Total, all-cause mortalityHigh Dose Condition (Group)
Total, other adverse eventsLow Dose Condition (Group)1056
Total, other adverse eventsHigh Dose Condition (Group)2356
Total, serious adverse eventsLow Dose Condition (Group)056
Total, serious adverse eventsHigh Dose Condition (Group)056

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
27909165RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Low Dose Condition (Group) vs High Dose Condition (Group): serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00465595

GET https://conductscience.org/api/trials/v1/NCT00465595/registered