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NCT06564818RECRUITINGIRB Ready

"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"

(APPROACH)

Sponsored by Cybin IRL Limited

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 220 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this study is to examine the efficacy, safety, and tolerability of CYB003 compared to matching placebo as adjunctive treatment in participants with MDD.

Who Can Participate

Inclusion Criteria

Participants must meet all the following criteria to be included in the trial:
Aged 18 to 85 years inclusive, at Screening
Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \[if single episode, duration of โ‰ฅ4 weeks and โ‰ค24 months\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.
Depression is of moderate to severe degree at Screening, independently confirmed by additional clinical assessments
Participant has been on a stable dose of a single antidepressant medication at an adequate dose (label specified) for an adequate duration in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator and clinical interviews.
Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI โ‰ค 40 kg/m2), inclusive, at Screening.
Participant is able to refrain from nicotine use during the dosing s

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

220 participants

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Age Range

18 Years - 85 Years

โšง

Gender

ALL

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Sponsor

Cybin IRL Limited

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
NOT_YET_RECRUITING

Phoenix

Arizona

Location available
View Phoenix location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

Bellflower

California

Location available
View Bellflower location page
RECRUITING

La Jolla

California

Location available
View La Jolla location page
NOT_YET_RECRUITING

Los Angeles

California

Location available
View Los Angeles location page
RECRUITING

Montclair

California

Location available
View Montclair location page
RECRUITING

Oceanside

California

Location available
View Oceanside location page

๐Ÿ“ And 36 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Major Depressive Disorder Treatment in Phoenix?

Join others in Arizona exploring innovative treatment options through clinical research

Major Depressive Disorder Treatment Options in Phoenix, Arizona

If you're searching for Major Depressive Disorder treatment in Phoenix, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Phoenix, Tucson, Tucson and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Major Depressive Disorder. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 220 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Major Depressive Disorder?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Major Depressive Disorder

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Major Depressive Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06564818. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.