Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Sunstone Medical
Must not be taking: Antidepressants, Antipsychotics, Cannabis, others
Disqualifiers: Schizophrenia, Bipolar, Substance use, others
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This is a Phase 2, single-center study to explore the efficacy, safety, and tolerability of up to two 25-mg doses of psilocybin administered at an interval of 9 to 10 weeks in patients with MDD and cancer. This two-part study will administer a fixed dose (25 mg) of psilocybin in a double-blind, randomized, placebo-controlled portion (Dosing Session 1) and subsequently allow rollover into an open-label portion (Dosing Session 2; fixed dose of psilocybin, 25 mg) for patients who do not achieve remission of MDD symptoms after the first dose.
In Dosing Session 1, groups of two to four patients will be randomized, as a cohort, to receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session, with each patient supported by their dedicated study therapist and monitored by a second therapist via video feed.
In Dosing Session 2, all eligible participants (i.e., patients who have not achieved remission defined as MADRS \< 10 at V7) will receive psilocybin 25 mg in an open-label fashion using the group session model. The study population will include adult men and women who are 18 years of age or older and have diagnoses of both MDD and a malignant neoplasm. MDD is defined as the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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 International Classification of Diseases, 10th edition (ICD-10). Participants will be recruited through referrals from specialized psychiatric and oncology services as well as through patient self-referrals.
The majority of participants will have no prior exposure to psilocybin or so-called "magic mushrooms"; however, participants with prior recreational experience with psilocybin or "magic mushrooms" are eligible.
Will I have to stop taking my current medications?
The trial requires that participants are not currently taking any antidepressant, antipsychotic medications, or medical cannabis at the start of the study. If you are on these medications, you would need to stop them before participating.
What data supports the effectiveness of the drug psilocybin for depression in adults with cancer?
Research shows that psilocybin can reduce symptoms of depression, including in cancer patients, and has been effective in treating major depressive disorder. Studies also suggest that psilocybin-assisted therapy can provide rapid and substantial antidepressant effects.
12345Is psilocybin safe for humans?
Psilocybin has been studied in clinical trials and is generally considered safe for humans when used in controlled settings, although it can cause temporary effects like hallucinations and changes in perception. A pilot study in cancer patients with depression found it to be safe, and a systematic review highlighted its safety in treating depression and anxiety in life-threatening diseases.
56789How is the drug psilocybin unique in treating depression in adults with cancer?
Psilocybin is unique because it can rapidly reduce symptoms of depression with just one or two doses, unlike many traditional antidepressants that require daily use. It works by altering brain activity and perception, which may help patients with cancer experience relief from depression and anxiety more quickly.
1271011Eligibility Criteria
Adults with both Major Depressive Disorder (MDD) and cancer, who are not on antidepressants or antipsychotics, can join this trial. They must have a depression score of ≥20 and be able to consent. Pregnant women, those with recent drug abuse or certain medical conditions like heart issues or uncontrolled diabetes cannot participate.Inclusion Criteria
Signed informed consent form (ICF)
I am 18 years old or older.
I have been diagnosed with major depression for at least 3 months.
+5 more
Exclusion Criteria
I am not taking any medications that affect my heart's rhythm.
Current (within the past year) alcohol or drug use disorder as defined by the DSM-5 (MINI 7.0.2) at Screening (V1)
A marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 ms at screening
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Dosing Session 1
Participants receive either psilocybin 25 mg or niacin 100 mg (active placebo) in a group session
1 day
1 visit (in-person)
Dosing Session 2
Eligible participants receive psilocybin 25 mg in an open-label group session
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
8 weeks
Multiple visits (in-person and virtual)
Participant Groups
The study tests if two doses of psilocybin (25 mg each) help adults with MDD and cancer feel better compared to a placebo. The first dose is given in a controlled setting; patients who don't improve may receive another dose openly later.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PsilocybinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Psilocybin is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Psilocybin for:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
🇪🇺 Approved in European Union as Psilocybin for:
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sunstone Medical, PCRockville, MD
Loading ...
Who Is Running the Clinical Trial?
Sunstone MedicalLead Sponsor
References
Assessing potential of psilocybin for depressive disorders. [2023]There has been increasing interest in the role psilocybin may play in the treatment of depressive disorders. Several clinical trials have shown psilocybin to have efficacy in reducing symptoms of depression.
Dose effect of psilocybin on primary and secondary depression: a preliminary systematic review and meta-analysis. [2022]Previous studies have shown that psilocybin has antidepressant effects. In the current study, we aim to explore the dose effects of psilocybin on primary (major depression patients) and secondary depression (depressed cancer patients).
Therapeutic Effects of Medicinal Mushrooms on Gastric, Breast, and Colorectal Cancer: A Scoping Review. [2023]Cancer is the leading cause of mortality globally. With anticancer medications causing severe adverse effects, understanding the role of alternative and efficacious anticancer treatments with minimal or no side effects can be beneficial. Edible mushrooms have been associated with certain health benefits and exhibit a broad range of pharmacological activities, including anti-inflammatory and immunomodulating activities. The anticancer potential of different mushrooms is now being tested. The goal of this scoping review was to discuss the most recent and available evidence on the therapeutic uses of medicinal mushrooms in cancer treatment, specifically those cancers with some of the highest mortality rates (i.e., gastric, breast, and colorectal cancer). Randomly controlled trials, clinical trials, and retrospective cohort studies (with placebo group) with human subjects published between 2012-2023 were searched using the databases Embase, Ovid MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINHAL), and Alt HealthWatch. The initial search yielded 2,202 articles. After removing 853 duplicate citations, 1,349 articles remained and were screened for study eligibility and accessibility, leaving 26 articles. The inclusion and exclusion criteria were then used to assess the remaining 26 full-text articles and nine articles were selected for the final review. The characteristics of the nine studies reported the efficacy of medicinal mushrooms Lentinus edodes (Shiitake), Coriolus versicolor (Turkey Tail), and Agaricus Sylvaticus (Scaly Wood), in treating symptoms, medication side effects, anti-tumor effects, and survival outcomes in gastric, breast, and colorectal cancers. Findings from this review suggest that medicinal mushrooms have the potential to prevent lymph node metastasis, prolong overall survival, decrease chemotherapy-induced side effects (e.g., diarrhea, vomiting), affect the immune system, and help maintain immune function and quality of life in patients with certain cancers. More research is needed with human subjects using RCTs with larger samples to ensure accurate outcomes and ascertain the most efficacious dosages.
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]Preliminary data suggest that psilocybin-assisted treatment produces substantial and rapid antidepressant effects in patients with major depressive disorder (MDD), but little is known about long-term outcomes.
HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. [2023]Psilocybin-assisted psychotherapy shows promise in treating depression and existential distress in people with serious medical illness. However, its individual-based methodology poses challenges for scaling and resource availability. The HOPE trial (A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients with Cancer) is an Institutional Review Boards-approved open-label feasibility and safety pilot study examining psilocybin-assisted group therapy in cancer patients with a DSM-5 depressive disorder (including major depressive disorder as well as adjustment disorder with depressed mood). We report here the safety and clinical outcome measures including six-months follow up data.
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]Psilocybin is a psychedelic tryptamine that has shown promise in recent clinical trials for the treatment of depression and substance use disorders. This open-label study of the pharmacokinetics of psilocybin was performed to describe the pharmacokinetics and safety profile of psilocybin in sequential, escalating oral doses of 0.3, 0.45, and 0.6 mg/kg in 12 healthy adults.
The pharmacology of psilocybin. [2016]Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine) is the major psychoactive alkaloid of some species of mushrooms distributed worldwide. These mushrooms represent a growing problem regarding hallucinogenic drug abuse. Despite its experimental medical use in the 1960s, only very few pharmacological data about psilocybin were known until recently. Because of its still growing capacity for abuse and the widely dispersed data this review presents all the available pharmacological data about psilocybin.
[Hallucinogenic mushrooms]. [2018]The group of hallucinogenic mushrooms (species of the genera Conocybe, Gymnopilus, Panaeolus, Pluteus, Psilocybe, and Stropharia) is psilocybin-containing mushrooms. These "magic", psychoactive fungi have the serotonergic hallucinogen psilocybin. Toxicity of these mushrooms is substantial because of the popularity of hallucinogens. Psilocybin and its active metabolite psilocin are similar to lysergic acid diethylamide. These hallucinogens affect the central nervous system rapidly (within 0.5-1 hour after ingestion), producing ataxia, hyperkinesis, and hallucinations. In this review article there are discussed about history of use of hallucinogenic mushrooms and epidemiology; pharmacology, pharmacodynamics, somatic effects and pharmacokinetics of psilocybin, the clinical effects of psilocybin and psilocin, signs and symptoms of ingestion of hallucinogenic mushrooms, treatment and prognosis.
Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. [2020]Psilocybin is a naturally occurring tryptamine known for its psychedelic properties. Recent research indicates that psilocybin may constitute a valid approach to treat depression and anxiety associated to life-threatening diseases. The aim of this work was to perform a systematic review with meta-analysis of clinical trials to assess the therapeutic effects and safety of psilocybin on those medical conditions. The Beck Depression Inventory (BDI) was used to measure the effects in depression and the State-Trait Anxiety Inventory (STAI) was used to measure the effects in anxiety. For BDI, 11 effect sizes were considered (92 patients) and the intervention group was significantly favored (WMD = -4.589; 95% CI = -4.207 to -0.971; p-value = 0.002). For STAI-Trait, 11 effect sizes were considered (92 patients), being the intervention group significantly favored when compared to the control group (WMD = -5.906; 95% CI = -7.852 to -3.960; p-value ˂ 0.001). For STAI-State, 9 effect sizes were considered (41 patients) and the intervention group was significantly favored (WMD = -6.032; 95% CI = -8.900 to -3.164; p-value ˂ 0.001). The obtained results are promising and emphasize the importance of psilocybin translational research in the management of symptoms of depression and anxiety, since the compound may be effective in reducing symptoms of depression and anxiety in conditions that are either resistant to conventional pharmacotherapy or for which pharmacologic treatment is not yet approved. Moreover, it may be also relevant for first-line treatment, given its safety.
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. [2022]Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression.
Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. [2022]Major depressive disorder (MDD) is a substantial public health burden, but current treatments have limited effectiveness and adherence. Recent evidence suggests that 1 or 2 administrations of psilocybin with psychological support produces antidepressant effects in patients with cancer and in those with treatment-resistant depression.