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Not Yet RecruitingNCT07210112

Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)

This study is not yet recruiting. It focuses on depression and currently lists study information in France.

DepressionDrugOver 18 Years
In plain English

Key information made simple

This study is comparing Psilocybin 25 mg per os with placebo for people with Depression - depression or Treatment-resistant Depression. Participants receive Psilocybin 25 mg per os or placebo and complete study visits and assessments. Some participants may receive placebo instead of the study treatment, and 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 GHU Paris Psychiatrie and Neurosciences. 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 and being able to understand the study and consent, while common reasons not to take part include active substance or alcohol problems that could affect the results and safety concerns that need urgent care first. 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
Depression - Major Depressive Disorder; Treatment-resistant Depression (TRD)
Study status
Not Yet Recruiting
Sponsor / lead affiliation
Centre Hospitalier St Anne
Location / country
France
Registry
ClinicalTrials.gov
Why this study may matter

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

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.

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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 France.

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
Centre Hospitalier St Anne
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
Not Yet Recruiting
Source
Official registry link
FAQ

Questions about this study

What is Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)?

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. It includes a comparison with placebo. Direct benefit is not guaranteed.

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

This study is sponsored by Centre Hospitalier St Anne. 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.

Efficacy of Psilocybin and Trazodone Combination. — Depression Clinical Trial | HopeStage