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NMDA receptor antagonist

Intranasal (esketamine) Ketamine with Treatment as Usual for Depression (ZYL-730-01 Trial)

Phase 2

Waitlist Available

Led By Pierre Chue, MBBCh

Research Sponsored by Zylorion Health

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, day 2, 5, 9, 12,16, ,19, 23, 26 and 28

Awards & highlights

ZYL-730-01 Trial Summary

This trialtests whether adding almond therapy to esketamine can help people better than just esketamine alone.

Eligible Conditions

Treatment-Resistant Depression

ZYL-730-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, day 2, 5, 9, 12, 16, 19, 23, 26 and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, day 2, 5, 9, 12, 16, 19, 23, 26 and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, day 2, 5, 9, 12, 16, 19, 23, 26 and 28 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 28

Secondary outcome measures

Change in Generalized Anxiety Disorder Questionnaire (GAD-7)

Change in Patient Health Questionnaire (PHQ-9)

Change in Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)

+2 more

ZYL-730-01 Trial Design

2Treatment groups

Experimental Treatment

Group I: Intranasal (esketamine) Ketamine with Treatment as UsualExperimental Treatment2 Interventions

Intranasal (esketamine) Ketamine - Dose of 56 mg for a maximum of 2 weeks, followed by 56mg or 84mg twice a week for a total of 8 doses during the 28 day study.

Group II: Intranasal (esketamine) Ketamine with Addition of Almond therapyExperimental Treatment2 Interventions

Intranasal (esketamine) Ketamine - Dose of 56mg for a maximum of 2 weeks, followed by 56 mg or 84mg twice a week for a total of 8 doses during the 28 day study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treatment as Usual

2016

Completed Phase 3

~2710

Psychotherapy

2020

Completed Phase 3

~3120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Zylorion HealthLead Sponsor

1 Previous Clinical Trials

1 Trials studying Depression

Pierre Chue, MBBChPrincipal InvestigatorAmygdala Associates

1 Previous Clinical Trials

1 Trials studying Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently looking for participants?

"Affirmative. Clinicaltrials.gov shows that this research, first posted on October 13th 2022, is presently looking for enrollees. 102 individuals must enroll at one medical centre to complete the trial."

Answered by AI

What is the magnitude of participants in this clinical experiment?

"Affirmative. Entries on clinicaltrials.gov conclusively demonstrate that this investigation is currently seeking patients, having been initiated on October 13th 2022 and amended most recently on November 9th 2022. 102 individuals are required from a solitary medical centre for the trial to be completed successfully."

Answered by AI

Who is eligible to participate in this research experiment?

"The prerequisites for this trial necessitate that applicants have a diagnosis of unipolar depression and be aged between 18 to 64. All told, 102 participants are required in order to complete the study."

Answered by AI

Are the eligibility requirements of this trial inclusive to those aged 70 and above?

"The inclusion criteria for this trial necessitate that participants are aged 18 or more, yet less than 64 years of age."

Answered by AI

How efficacious is this procedure for those under its care?

"Due to the Phase 2 status of this trial, there is partial evidence that suggests safety but no data available yet for efficacy. Therefore, our team rated the safety as a score of 2 on a 1-3 scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression

2022. "Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05323019.