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Arm A for Depression and Anxiety

Phase 2

Recruiting

Led By Moran Amit, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an ECOG performance status of 0, 1, or 2

Participants must have one of the specified histology documented tumor types

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial aims to investigate whether using psilocybin-assisted therapy can help patients with advanced cancer who are also suffering from depression and/or anxiety. The study will focus on assessing the safety and potential

Who is the study for?

This trial is for patients with advanced cancer who are currently on maintenance therapy and experiencing depression and/or anxiety. Participants should be interested in exploring psilocybin-assisted psychotherapy.Check my eligibility

What is being tested?

The study investigates the use of psilocybin, a compound found in magic mushrooms, alongside psychotherapy to see if it can help reduce depression or anxiety in those undergoing treatment for advanced cancer.See study design

What are the potential side effects?

Psilocybin may cause temporary changes in perception, mood swings, dizziness, headaches, nausea or an increase in heart rate. These effects are generally short-lived.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My cancer type is confirmed by a lab test.

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My cancer has spread, didn't fully respond to treatment but is now stable.

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I haven't had severe side effects from my current cancer treatment.

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I am mentally alert and aware of who I am, where I am, and the current time.

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I am 25 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment2 Interventions

Participants will receive psilocybin (25 mg).

Group II: Arm BPlacebo Group2 Interventions

Participants will receive the placebo (100 mg of Niacin).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~730

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,533 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,489 Total Patients Enrolled

Moran Amit, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enroll participants in this clinical trial?

"According to the information available on clinicaltrials.gov, this particular study is not currently accepting new patients. The trial was initially posted on June 30th, 2024, and its most recent update occurred on December 28th, 2023. Despite this study being closed for recruitment at the moment, there are a total of 4177 other ongoing studies that are actively enrolling participants."

Answered by AI

What is the level of safety associated with Arm A in regards to individuals?

"Based on the classification of this trial as Phase 2, our team at Power rates the safety of Arm A with a score of 2. This is because there exists limited data supporting its safety but no evidence yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

2024. "Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06200155.

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