Active Not RecruitingNCT04433858

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

This study is active but not recruiting. It focuses on depression and currently lists study information in the United States.

DepressionDrugFrom 18 Years to 65 Years

In plain English

Key information made simple

This study is looking at care and outcomes for people with Treatment Resistant Depression. Taking part may give some people access to Psilocybin, but direct benefit is not guaranteed.

What to expect

Your next step

The official record suggests in-person participation through a research setting, with sites including VA Palo Alto Healthcare System/Stanford Medicine and Sheppard Pratt Health System in Baltimore. Participation appears to involve guided sessions or support activities with check-ins on how they fit into daily life. The main fit is usually matching the main diagnosis, while common reasons not to take part include other factors that could make participation unsuitable. This is an early-stage study, which usually means a smaller group and a focus on learning how the approach behaves.

Public study data

Key study information

Condition: Treatment Resistant Depression
Study status: Active Not Recruiting
Sponsor / lead affiliation: Sheppard Pratt Health System
Location / country: United States
Registry: ClinicalTrials.gov

Why this study may matter

This study may matter because it adds public evidence around depression. HopeStage presents it as a starting point for understanding the study, checking the official source, and preparing questions with a care team.

Before joining

Questions to ask before joining

What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?

Official source

Registry reference

This page links back to the public source record so people can verify details directly with the registry and research team.

If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.

Open source record

Need help deciding?

Ask HopeStage to review this study with me

This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.

Study reference: NCT04433858. We only ask for your email here. HopeStage can help you review the study, but this is not a medical eligibility decision.

In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Requires travel, with in-person participation in United States.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

Study clarity

Things to check before joining

Sponsor: Sheppard Pratt Health System
Sponsor type: Unknown or unclear
Main activity: medication or study treatment
Intervention: Not available
Time commitment: multiple visits or assessments
Study phase: Not available
Enrollment: Not available
Recruitment status: Active Not Recruiting
Source: Official registry link

FAQ

Questions about this study

What is An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)?

This study is exploring medication or study treatment for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by Sheppard Pratt Health System. We could not clearly classify the sponsor type from the available data. Check the official source record to verify who is responsible for the study.

What does participation involve, what phase is it, and what should I ask about safety?

This study may involve medication or study treatment, study visits, and assessments. The time commitment is multiple visits or assessments. The study phase is not available in HopeStage data. Check the official source record to see whether a phase is listed. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.

Where can I verify the study details?

Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.