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CYB004 for Generalized Anxiety Disorder

Verified Trial

Phase 1 & 2

Recruiting

Research Sponsored by Cybin IRL Limited

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Have you been diagnosed with Bipolar Disorder?

Have you been diagnosed with ADHD?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening (day-28 and day-1), day 1, day 8, day 15, day 21, day 23, day 43, day 64, day 85, day 106, day day 127, day 148, and end of treatment (day 169)

Awards & highlights

No Placebo-Only Group

Summary

The purpose of this trial is to examine the preliminary clinical efficacy of CYB004 participants with GAD.

Who is the study for?

This trial is for adults aged 18-65 with Generalized Anxiety Disorder, who haven't responded well to stable doses of antidepressants. Participants must have a BMI between 18-40 inclusive and not be taking certain medications or have specific health conditions that could affect the study.

What is being tested?

The trial is testing CYB004 (a DMT analog) alongside psychotherapy for safety, tolerability, and initial effectiveness in treating anxiety with depressive symptoms. It's a proof-of-concept study focusing on individuals diagnosed with GAD.

What are the potential side effects?

While the side effects are being studied as part of this trial's purpose, potential risks may include typical psychedelic-related effects such as sensory alterations and psychological distress. The exact profile will be clearer after the study.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening (day-28 and day-1), day 1, day 8, day 15, day 21, day 23, day 43, day 64, day 85, day 106, day day 127, day 148, and end of treatment (day 169)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening (day-28 and day-1), day 1, day 8, day 15, day 21, day 23, day 43, day 64, day 85, day 106, day day 127, day 148, and end of treatment (day 169)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (day-28 and day-1), day 1, day 8, day 15, day 21, day 23, day 43, day 64, day 85, day 106, day day 127, day 148, and end of treatment (day 169) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hamilton Anxiety Rating Scale (HAM-A)

Secondary study objectives

Hamilton Depression Scale (HAM-D)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: ActiveExperimental Treatment2 Interventions

Arm A participants will receive a full dose of CYB004 in 2 of 2 medicine sessions, approximately three weeks apart. All participants will receive supportive EMBARK psychotherapy throughout the study.

Group II: Arm B: ControlActive Control2 Interventions

Arm B participants will receive a low dose of CYB004 in 2 of 2 medicine sessions, approximately three weeks apart. All participants will receive supportive EMBARK psychotherapy throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psychotherapy

2014

Completed Phase 3

~3440

0 / 5Eligibility criteria met