Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlan Davis
About this trial
This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals diagnosed with NSCLC, confirmed by pathology report
Have a Karnofsky performance status >= 60
Participants receiving chemotherapy, radiation therapy, and biologic therapies may participate while receiving those therapies if they are tolerating the therapy or treatment sufficiently to allow administration of oral psilocybin and if treatments do not result in meeting any of the medical
Disqualifiers
Moderate to severe symptoms of depression (GRID Hamilton Rating Scale for Depression [GRID-HAMD] > 16)
English-speaking
Over the age of 18
Have given written informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo blood and urine sample collection
Counseling
Other interventionParticipate in therapy sessions
Interview
Other interventionAncillary studies
Psilocybin
DrugGiven PO
Survey Administration
Other interventionAncillary studies
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Supportive Care (counseling sessions, psilocybin)Experimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS)
Ratings of suicidal ideation on the C-SSRS will be summarized with means and standard deviations (SD) at baseline, one day post-drug session, and 4 weeks post-drug session. A mixed effects regression model will be fit containing a fixed effect for visit to test for a significant change in ratings of suicidal ideation from baseline to 4 weeks post drug session. Estimated mean differences will be presented with corresponding 95% confidence intervals (CI). An alpha level of 0.05 will be used to determine statistical significance.
Time frame
At baseline, one day post-drug session, and 4 weeks post-drug session2
Incidence of adverse events
Descriptive analysis of adverse event reporting logs will be conducted to determine if any serious adverse events have been reported related to psilocybin administration.
Time frame
At baseline, one day post-drug session, and 4 weeks post-drug session3
Acceptability of psilocybin-assisted therapy
The mean (SD) change in Participant/Client Satisfaction Questionnaire levels between end of preparatory session 2 (visit 3; 7 days prior to drug administration) and 4 weeks post-drug session will be presented and a paired t-test will be used to test for a significant increase/decrease in acceptability. The estimated mean change will be presented with corresponding 95% confidence interval (CI). An alpha level of 0.05 will be used to determine statistical significance.
Time frame
At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session4
Satisfaction of psilocybin-assisted therapy
The mean (SD) change in Participant/Client Satisfaction Questionnaire levels between end of preparatory session 2 (visit 3; 7 days prior to drug administration) and 4 weeks post-drug session will be presented and a paired t-test will be used to test for a significant increase/decrease in satisfaction. The estimated mean change will be presented with corresponding 95% confidence interval (CI). An alpha level of 0.05 will be used to determine statistical significance.
Time frame
At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug sessionSecondary outcomes
1
Depression symptom severity
Mean (SD) ratings of depression symptom severity will be presented from baseline, end of preparatory session 2 (visit 3; 7 days prior to drug administration), and 4 weeks post-drug session. A mixed effects regression model will be fit containing a fixed effect for visit to test for a significant change in ratings of depressive symptom severity from baseline to 4 weeks post drug session. Estimated mean differences will be presented with corresponding 95% confidence intervals (CI). An alpha level of 0.05 will be used to determine statistical significance.
Time frame
At baseline, end of visit 3 (7 days prior to drug administration), and 4 weeks post-drug session.2
Quality of life (Medical Outcomes Study-Short Form-12)
The Medical Outcomes Study-Short Form-12 (SF-12) is a 12-item self-report measure assessing health- related quality of life during the past month.184 The SF-12 assesses eight aspects of quality of life including physical functioning, role functioning physical, general health perceptions, vitality, social functioning, role functioning emotion, and mental health. Scores from the eight are weighted and summed for two scores: physical component summary (PCS) and mental component summary (MCS) score. Mean (SD) ratings for each of the quality of life measures will be presented.
Time frame
AT baseline, preparatory session 2, and 4 weeks post-drug session3
Quality of Life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) is a common, validated measure assessing the frequency of common symptoms of lung cancer and lung cancer treatments.The EORTC QLQ-LC 13 contains nine items that assess individual symptoms (e.g., pain, coughing) and one three-item symptom scale that assesses dyspnea. Patients rated the extent to which each symptom was experienced in the past week on a 4-point Likert scale (1=not at all to 4=very much). Each item is transformed to a score ranging 0-100, with lower scores indicating better health-related quality of life and lower symptoms. Mean (SD) ratings for each of the quality of life measures will be presented.
Time frame
At baseline, preparatory session 2, and 4 weeks post-drug session4
Quality of Life (Impact of Events Scale-Revised)
The Impact of Events Scale-Revised is a 22-item expansion of the original 15-item IES which assesses subjective distress caused by any specific life event.The items and 3 subscales (Intrusion, Avoidance, and Hyperarousal) correspond closely with the symptoms associated with a DSM-IV diagnosis of PTSD. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") to yield a total score (ranging from 0 to 88). Mean (SD) ratings for each of the quality of life measures will be presented.
Time frame
At baseline, preparatory session 2, and 4 weeks post-drug sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Alan Davis
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov