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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | GRID-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 |
| Primary | HAM-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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | Baseline, 5 weeks post session 1 and 2, 6-month follow-up | units on a scale | MEAN | |
| PRIMARY | HAM-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 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | Low-Dose First Baseline | 22.32 | Standard Error .88 | units on a scale | |
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | Low-Dose First Post Session 1 | 14.8 | Standard Error 1.45 | units on a scale | |
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | Low-Dose First Post Session 2 | 6.5 | Standard Error .86 | units on a scale | |
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | Low-Dose First 6 Month | 6.95 | Standard Error 1.24 | units on a scale | |
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | High-Dose First Baseline | 22.84 | Standard Error .97 | units on a scale | |
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | High-Dose First Post Session 1 | 6.64 | Standard Error 1.04 | units on a scale | |
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | High-Dose First Post Session 2 | 6.52 | Standard Error 1.44 | units on a scale | |
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | High-Dose First 6 Month | 6.23 | Standard Error 1.3 | units 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 Baseline | 25.68 | Standard Error .89 | units 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 1 | 16.64 | Standard Error 1.53 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low-Dose First | 27 | |
| Overall Study | STARTED | High-Dose First | 29 | |
| Overall Study | COMPLETED | Low-Dose First | 22 | |
| Overall Study | COMPLETED | High-Dose First | 24 | |
| Overall Study | NOT COMPLETED | Low-Dose First | 5 | |
| Overall Study | NOT COMPLETED | High-Dose First | 5 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Elevated Systolic Blood Pressure | Cardiac disorders | Low Dose Condition (Group) | 9 | 56 | |
| other | Elevated Systolic Blood Pressure | Cardiac disorders | High Dose Condition (Group) | 16 | 56 | |
| other | Elevated Diastolic Blood Pressure | Cardiac disorders | Low Dose Condition (Group) | 1 | 56 | |
| other | Elevated Diastolic Blood Pressure | Cardiac disorders | High Dose Condition (Group) | 7 | 56 | |
| other | Nausea | General disorders | Low Dose Condition (Group) | 0 | 56 | |
| other | Nausea | General disorders | High Dose Condition (Group) | 7 | 56 | |
| other | Anxiety Episode | Psychiatric disorders | Low Dose Condition (Group) | 7 | 56 | |
| other | Anxiety Episode | Psychiatric disorders | High Dose Condition (Group) | 13 | 56 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Condition (Group) | ||
| Total, all-cause mortality | High Dose Condition (Group) | ||
| Total, other adverse events | Low Dose Condition (Group) | 10 | 56 |
| Total, other adverse events | High Dose Condition (Group) | 23 | 56 |
| Total, serious adverse events | Low Dose Condition (Group) | 0 | 56 |
| Total, serious adverse events | High Dose Condition (Group) | 0 | 56 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27909165 | RESULT |
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 |
Source Trial comparisons
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.
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