Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593563
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Maryland Oncology Hematology, PA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Psilocybin Phase 2

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psilocybin 25mg
Psilocybin 25mg Single does with supportive conditions.
Drug: Psilocybin
Single 5 capsule oral psilocybin dose: 25mg: 5 x 5 mg capsules.




Primary Outcome Measures :
  1. 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


  2. 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.

  3. Maudsley Visual Analogue Scale (VAS) current [ Time Frame: 8 weeks ]
    Minimum score: -50 Maximum Score: 50 Higher score is indicative of a better outcome.

  4. 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.

  5. 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.

  6. 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


  7. 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.

  8. 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.

  9. 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.


  10. 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.

  11. 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.

  12. 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.


  13. Sheehan Disability Score (SDS) [ Time Frame: 8 weeks ]
    SDS score change from Baseline Minimum: 0 Maximum: 30 Higher Score is indicative of worsening outcome.

  14. 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.

  15. 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.

  16. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed ICF
  2. 18 years of age or above at Screening (V1)
  3. 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
  4. 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)
  5. HAM D 17 score ≥18 at Screening (V1) and at Baseline (V2)
  6. Are not currently taking any antidepressant and/or antipsychotic medications, or medical cannabis, at Screening (V1)
  7. Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
  8. Has capacity to consent (assessed via investigator judgement)

Exclusion Criteria:

Psychiatric Exclusion Criteria:

  1. 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)
  2. Current (within the past year) alcohol or drug use disorder as defined by DSM 5 (MINI 7.0.2) at Screening (V1)
  3. 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
  4. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin

    General Medical Exclusion Criteria:

  5. 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)
  6. 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
  7. Uncontrolled or insulin dependent diabetes
  8. Seizure disorder
  9. 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
  10. Current enrollment in any investigational drug or device study or participation in such within 30 days of Screening.
  11. 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
  12. 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
  13. Use of psychedelics, including psilocybin but excluding medical marijuana, within the past 12 months and use of psychedelics during the current episode of depression
  14. Concurrent or recent chemotherapy or radiation therapy, that impairs general level of phsyical functioning.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593563


Locations
Layout table for location information
United States, Maryland
Maryland Oncology Hematology PA Recruiting
Rockville, Maryland, United States, 20850
Contact: Azeem Bhatti    240-826-2120    azeem.bhatti@usoncology.com   
Contact: Linda Iovanni    240-826-2120    linda.iovanni@usoncology.com   
Principal Investigator: Manish Agrawal, MD         
Sub-Investigator: Paul Thambi, MD         
Sponsors and Collaborators
Maryland Oncology Hematology, PA
Layout table for additonal information
Responsible Party: Maryland Oncology Hematology, PA
ClinicalTrials.gov Identifier: NCT04593563    
Other Study ID Numbers: 49347
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maryland Oncology Hematology, PA:
Cancer
Major Depressive Disorder
psychedelics
Psilocybin
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs