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CYB004 + Psychotherapy for Generalized Anxiety Disorder

Phase 1 & 2

Waitlist Available

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

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

Study Summary

This trial studies a potential new treatment to reduce symptoms of anxiety and depression.

Who is the study for?

This trial is for adults aged 21-65 with Generalized Anxiety Disorder and moderate to severe depression, who haven't responded well to stable doses of antidepressants. Participants must be non-smokers, have a BMI of 18-37.5, weigh at least 60 kg, and not be taking certain medications or have specific health conditions that could affect the study.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Hamilton Anxiety Rating Scale (HAM-A)

Secondary outcome measures

Hamilton Depression Scale (HAM-D)

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

2020

Completed Phase 3

~3120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cybin IRL LimitedLead Sponsor

1 Previous Clinical Trials

57 Total Patients Enrolled

Worldwide Clinical TrialsOTHER

61 Previous Clinical Trials

14,351 Total Patients Enrolled

Drug Safety NavigatorUNKNOWN

1 Previous Clinical Trials

57 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 minors accepted for participation in this medical experiment?

"Individuals aged between 18 and 65 are being sought out to participate in this investigation."

Answered by AI

Could I potentially qualify to participate in this research?

"This research study is accepting applicants living with generalized anxiety disorder and aged between 18 to 65. Approximately 36 volunteers will be accepted into the trial."

Answered by AI

Are there still spots available for this research project?

"The details on clinicaltrials.gov demonstrate that recruiting for this particular medical study has ceased; it was originally posted in June 2024 and last amended in September 2023. However, there are 1,556 other trials registering participants at the present time."

Answered by AI