Major Depressive DisorderPhase 2NCT04593563

The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder

A Phase 2 study testing Psilocybin in people with Major Depressive Disorder, run by Maryland Oncology Hematology, PA at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Psilocybin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2020to Oct 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed ICF
18 years of age or above at Screening (V1)
Currently meet criteria for MDD (single or recurrent episode as defined by DSM 5; if single episode, duration of more or equal to 3 months) based on medical records, clinical assessment and documented completion of the MINI version 7.0.2
A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10)
HAM D 17 score ≥18 at Screening (V1) and at Baseline (V2)
Are not currently taking any antidepressant and/or antipsychotic medications, or medical cannabis, at Screening (V1)
Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
Has capacity to consent (assessed via investigator judgement)

Who cannot join

Psychiatric Exclusion Criteria:
Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history and a structured clinical interview (MINI version 7.0.2)
Current (within the past year) alcohol or drug use disorder as defined by DSM 5 (MINI 7.0.2) at Screening (V1)
Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during subject interview
Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin
General Medical Exclusion Criteria:

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Women who are pregnant, nursing, or planning a pregnancy. Women and men of child bearing potential and who are sexually active must agree to use an acceptable contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening (V1) and Baseline (V2)
Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent myocardial infarction (<1 year from signing of ICF), uncontrolled hypertension (blood pressure >140/90) or clinically significant arrhythmia within 1 year of signing the ICF
Uncontrolled or insulin dependent diabetes
Seizure disorder
Positive urine drug screen for illicit drugs or drugs of abuse at V1 and V2. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion in conjunction with the medical monitor
Current enrollment in any investigational drug or device study or participation in such within 30 days of Screening.
Abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at Screening (V1) that in the investigator's opinion may consistute a risk for an individual who is explosed to psilocybin. This includes platelets below 50,000 platelets per cubic millimeter of blood, liver function tests three times the upper limit of normal, creatine two times above the normal range. Clinically significant abnormal electrolytes or low hemoglobin (below 8 g/L) should be corrected and rechecked
Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study
Use of psychedelics, including psilocybin but excluding medical marijuana, within the past 12 months and use of psychedelics during the current episode of depression
Concurrent or recent chemotherapy or radiation therapy, that impairs general level of phsyical functioning.

Trial locations and contacts

1 site in 1 country.

United States1 site

Maryland Oncology Hematology PA
Rockville, Maryland, 20850

Other trials in United States

About this study

This is a Phase II, single-center, fixed dose, open label trial to explore the safety, tolerability and efficacy of a 25mg dose of psilocybin in cancer patients with MDD. The study population will include adult men and women, 18 years of age or above, with MDD, diagnosed with a malignant neoplasm. MDD is defined as those who meet DSM 5 diagnostic criteria for a single or recurrent episode of MDD without psychotic features. A diagnosis of a malignant neoplasm is defined as having a diagnostic code from C00 to C97 according to the ICD-10.

Read the detailed description

Recent randomized, placebo-controlled clinical trials of psilocybin therapy for anxiety and depression associated with cancer diagnosis showed significant improvement in study endpoints reflecting psychological distress, as compared to placebo. The effects of a single psilocybin therapy session endured for up to six months with no specific follow-up care. In this study, we aim to explore the safety and efficacy of psilocybin therapy in cancer patients, diagnosed with Major Depressive Disorder (MDD).

Conditions: Major Depressive Disorder
Being tested: Psilocybin
Keywords: Cancer, Major Depressive Disorder, psychedelics, Psilocybin
Medical subject headings: Depressive Disorder, Major, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PsilocybinDrug
Single 5 capsule oral psilocybin dose: 25mg: 5 x 5 mg capsules.

Study groups in NCT04593563
Study group	Role	What they receive
Psilocybin 25mg	Experimental	Psilocybin 25mg Single does with supportive conditions. Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

The Montgomery-Åsberg Depression Rating Scale (MADRS)
Ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.
Minimum Score: 0 Maximum Score: 60 Higher Score is indicative of greater depression
Measured: 8 weeks
Quick Inventory of Depressive Symptomatology Self reported (QIDS-SR)
16-Item quick inventory of depressive symptomatology. Minimum score: 0 Maximum Score: 16 Higher Score is indicative of worsening depression.
Measured: 8 weeks
Maudsley Visual Analogue Scale (VAS) current
Minimum score: -50 Maximum Score: 50 Higher score is indicative of a better outcome.
Measured: 8 weeks
Maudley Visual Analogue Scale (VAS) Change.
Change in Maudsley VAS change scores from Baseline Minimum score: -50 Maximum Score: 50 Higher score is indicative of a better outcome.
Measured: 8 weeks
Pain Visual Analogue Score (VAS)
Change in use of pain medications from Baseline (Day -1 [V2]) to Week 8 (V7) Minimum score: 0 Maximum Score: 10 Higher score is not indicative of a better outcome.
Measured: 8 weeks
Hamilton Anxiety Rating Scale-A (HAM-A)
The Hamilton Anxiety Rating Scale (HAM-A) is a widely used and well-validated tool for measuring the severity of a patient's anxiety. It should be administered by an experi- enced clinician. The HAM-A probes 14 parameters and takes 15-20 minutes to complete the interview and score the results. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe.
Minimum Score: 0 Maximum Score: 56 Higher Score is indicative of worsening Depression
Measured: 8 weeks
State-Trait Anxiety Inventory (STAI)
Psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis Minimum: 20 Maximum: 80 Higher Score is indicative of worsening outcome.
Measured: 8 weeks
National Institute of Health Healing Experience of All Life Stressors (NIH-HEALS)
Psycho-social-spiritual healing in NIH-HEALS total score change from Baseline (Day -1 [V2]) to Weeks 1 (V5), 3 (V6), and 8 (V7). Additionally changes in the three factor scores on this measure will be assessed for change at the same timepoints: Connection; Reflection and Introspection; Trust and Acceptance.Healing Experience of All Life Stressors (NIH-HEALS) was developed by the NIH Clinical Center Pain and Palliative Care Service as a psycho-social-spiritual measure of healing that assesses positive transformation in response to challenging life events. It is a self-report, 35-item questionnaire.
Measured: 8 weeks
Patient EQ-5D-5L
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Participant EQ 5D 5L score change from Baseline (Day -1 [V2]) to subsequent follow up visits.
Minimum: 0 Maximum: 20 Higher Score is indicative of worsening outcome.
Measured: 8 weeks
Caregiver Oncology Quality of Life Questionnaire (CarGOQol)
CarGOQol score change from Baseline (Day -1 [V2]) to subsequent follow up visits (this assessment is not mandatory) Minimum: 0 Maximum: 116 Higher Score is indicative of worsening outcome.
Measured: 8 weeks
DS-II
Change in DS-II factor scores from Baseline. Minimum: 0 Maximum: 32 Higher Score is indicative of worsening outcome.
Measured: 8 weeks
5 Dimension Altered State of Consciousness (5D-ASC)
Summary of the 5D-ASC on the day of psilocybin dosing. o Links between psychedelic intensity and experience (via the 5D-ASC) and depression and anxiety outcomes will also be explored and patient experience and acceptability of the treatment summarised at V3 and V4.
This has 11 subscales, and higher scores are indicative of good outcomes.
Measured: 8 weeks
Sheehan Disability Score (SDS)
SDS score change from Baseline Minimum: 0 Maximum: 30 Higher Score is indicative of worsening outcome.
Measured: 8 weeks
Scale To Assess Therapeutic Relationship: Patient (STAR-P)
Therapeutic alliance of the clinician and patient, as rated using the STAR-C and STAR-P respectively will be assessed at Baseline, along with assessing correlations with this measure and primary and secondary outcomes as a possible predictor of response Minimum: 0 Maximum: 48 Higher Score is indicative of good outcome.
Measured: 8 weeks
Scale To Assess Therapeutic Relationship: Clinician. (STAR-C)
Therapeutic alliance of the clinician and patient, as rated using the STAR-C and STAR-P respectively will be assessed at Baseline, along with assessing correlations with this measure and primary and secondary outcomes as a possible predictor of response Minimum: 0 Maximum: 48 Higher Score is indicative of good outcome.
Measured: 8 weeks
Changes in electrocardiographs.
Abnormal and clinically significant results on the ECG, that in the investigator's opinion may constitute a risk for an individual who is exposed to psilocybin.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2020Oct 2023

First posted20 Oct 2020
Study start1 Sep 2020
Primary completionOct 2022 (estimated)
Study completionOct 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04593563
Sponsor's protocol ID: 49347
Status last verified: Oct 2021
First submitted: 9 Sep 2020
Last updated: 15 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Agrawal M, Richards W, Beaussant Y, Shnayder S, Ameli R, Roddy K, Stevens N, Richards B, Schor N, Honstein H, Jenkins B, Bates M, Thambi P. Psilocybin-assisted group therapy in patients with cancer diagnosed with a major depressive disorder. Cancer. 2024 Apr 1;130(7):1137-1146. doi: 10.1002/cncr.35010. Epub 2023 Dec 18.
PubMed 38105655

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
ClinicalTrials.gov ID: NCT04593563
Acronym / sponsor ID: 49347
Conditions: Major Depressive Disorder
Keywords: Cancer, Major Depressive Disorder, psychedelics, Psilocybin
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (actual)
Lead sponsor: Maryland Oncology Hematology, PAUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: Oct 2022 (estimated)
Study completion: Oct 2023 (estimated)
First posted: 20 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Psilocybin 25mg	Experimental	Drug: PsilocybinPsilocybin 25mg Single does with supportive conditions.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Signed ICF
18 years of age or above at Screening (V1)
Currently meet criteria for MDD (single or recurrent episode as defined by DSM 5; if single episode, duration of more or equal to 3 months) based on medical records, clinical assessment and documented completion of the MINI version 7.0.2
A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10)
HAM D 17 score ≥18 at Screening (V1) and at Baseline (V2)

Key exclusion criteria (16 listed)

Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history and a structured clinical interview (MINI version 7.0.2)
Current (within the past year) alcohol or drug use disorder as defined by DSM 5 (MINI 7.0.2) at Screening (V1)
Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during subject interview
Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin
Women who are pregnant, nursing, or planning a pregnancy. Women and men of child bearing potential and who are sexually active must agree to use an acceptable contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening (V1) and Baseline (V2)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PsilocybinSingle 5 capsule oral psilocybin dose: 25mg: 5 x 5 mg capsules.	Drug	Psilocybin 25mg

Primary outcome

The Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 8 weeks
Ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Minimum Score: 0 Maximum Score: 60 Higher Score is indicative of greater depression
Quick Inventory of Depressive Symptomatology Self reported (QIDS-SR)
Time frame: 8 weeks
16-Item quick inventory of depressive symptomatology. Minimum score: 0 Maximum Score: 16 Higher Score is indicative of worsening depression.
Maudsley Visual Analogue Scale (VAS) current
Time frame: 8 weeks
Minimum score: -50 Maximum Score: 50 Higher score is indicative of a better outcome.
Maudley Visual Analogue Scale (VAS) Change.
Time frame: 8 weeks
Change in Maudsley VAS change scores from Baseline Minimum score: -50 Maximum Score: 50 Higher score is indicative of a better outcome.
Pain Visual Analogue Score (VAS)
Time frame: 8 weeks
Change in use of pain medications from Baseline (Day -1 [V2]) to Week 8 (V7) Minimum score: 0 Maximum Score: 10 Higher score is not indicative of a better outcome.
Hamilton Anxiety Rating Scale-A (HAM-A)
Time frame: 8 weeks
The Hamilton Anxiety Rating Scale (HAM-A) is a widely used and well-validated tool for measuring the severity of a patient's anxiety. It should be administered by an experi- enced clinician. The HAM-A probes 14 parameters and takes 15-20 minutes to complete the interview and score the results. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Minimum Score: 0 Maximum Score: 56 Higher Score is indicative of worsening Depression
State-Trait Anxiety Inventory (STAI)
Time frame: 8 weeks
Psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis Minimum: 20 Maximum: 80 Higher Score is indicative of worsening outcome.
National Institute of Health Healing Experience of All Life Stressors (NIH-HEALS)
Time frame: 8 weeks
Psycho-social-spiritual healing in NIH-HEALS total score change from Baseline (Day -1 [V2]) to Weeks 1 (V5), 3 (V6), and 8 (V7). Additionally changes in the three factor scores on this measure will be assessed for change at the same timepoints: Connection; Reflection and Introspection; Trust and Acceptance.Healing Experience of All Life Stressors (NIH-HEALS) was developed by the NIH Clinical Center Pain and Palliative Care Service as a psycho-social-spiritual measure of healing that assesses positive transformation in response to challenging life events. It is a self-report, 35-item questionnaire.
Patient EQ-5D-5L
Time frame: 8 weeks
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Participant EQ 5D 5L score change from Baseline (Day -1 [V2]) to subsequent follow up visits. Minimum: 0 Maximum: 20 Higher Score is indicative of worsening outcome.
Caregiver Oncology Quality of Life Questionnaire (CarGOQol)
Time frame: 8 weeks
CarGOQol score change from Baseline (Day -1 [V2]) to subsequent follow up visits (this assessment is not mandatory) Minimum: 0 Maximum: 116 Higher Score is indicative of worsening outcome.
DS-II
Time frame: 8 weeks
Change in DS-II factor scores from Baseline. Minimum: 0 Maximum: 32 Higher Score is indicative of worsening outcome.
5 Dimension Altered State of Consciousness (5D-ASC)
Time frame: 8 weeks
Summary of the 5D-ASC on the day of psilocybin dosing. o Links between psychedelic intensity and experience (via the 5D-ASC) and depression and anxiety outcomes will also be explored and patient experience and acceptability of the treatment summarised at V3 and V4. This has 11 subscales, and higher scores are indicative of good outcomes.
Sheehan Disability Score (SDS)
Time frame: 8 weeks
SDS score change from Baseline Minimum: 0 Maximum: 30 Higher Score is indicative of worsening outcome.
Scale To Assess Therapeutic Relationship: Patient (STAR-P)
Time frame: 8 weeks
Therapeutic alliance of the clinician and patient, as rated using the STAR-C and STAR-P respectively will be assessed at Baseline, along with assessing correlations with this measure and primary and secondary outcomes as a possible predictor of response Minimum: 0 Maximum: 48 Higher Score is indicative of good outcome.
Scale To Assess Therapeutic Relationship: Clinician. (STAR-C)
Time frame: 8 weeks
Therapeutic alliance of the clinician and patient, as rated using the STAR-C and STAR-P respectively will be assessed at Baseline, along with assessing correlations with this measure and primary and secondary outcomes as a possible predictor of response Minimum: 0 Maximum: 48 Higher Score is indicative of good outcome.
Changes in electrocardiographs.
Time frame: 8 weeks
Abnormal and clinically significant results on the ECG, that in the investigator's opinion may constitute a risk for an individual who is exposed to psilocybin.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
Derived from this study: PubMed 38105655Agrawal M, Richards W, Beaussant Y, Shnayder S, Ameli R, Roddy K, Stevens N, Richards B, Schor N, Honstein H, Jenkins B, Bates M, Thambi P. Psilocybin-assisted group therapy in patients with cancer diagnosed with a major depressive disorder. Cancer. 2024 Apr 1;130(7):1137-1146. doi: 10.1002/cncr.35010. Epub 2023 Dec 18.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with Major Depressive Disorder, run by Maryland Oncology Hematology, PA at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 8 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04593563, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.