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NMDA Receptor Antagonist

Ketamine for Major Depressive Episode

Phase 2

Waitlist Available

Led By Richard Idell, MD

Research Sponsored by The University of Texas Health Science Center at Tyler

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 4 weeks

Awards & highlights

Study Summary

This trial is testing whether the addition of music during a ketamine infusion will reduce suicidal ideation in patients with major depression. 50 individuals will receive ketamine + music, 50 will receive ketamine alone, 50 will receive music alone, and 50 will receive usual care without ketamine or music. The primary outcome is suicidal ideation scores on the Scale for Suicidal Ideation (SSI) 4 weeks after the ketamine infusion.

Eligible Conditions

Major Depressive Episode
Suicidal Thoughts

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Scale for Suicide Ideation (SSI)

Secondary outcome measures

Montgomery Asberg Depression Rating Scale (MADRS)

Quick Inventory of Depressive Symptomatology (QIDS SR-16)

Time of hospitalization

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: MusicExperimental Treatment1 Intervention

One hour of pre-planned music without ketamine

Group II: Ketamine + MusicExperimental Treatment2 Interventions

One group will receive IV ketamine 0.5mg/kg infused over forty minutes with one hour of pre-planned music

Group III: KetamineExperimental Treatment1 Intervention

One group will receive IV ketamine 0.5mg/kg infused over forty minutes

Group IV: Treatment as usualActive Control1 Intervention

No music nor ketamine given

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonOTHER

903 Previous Clinical Trials

320,777 Total Patients Enrolled

The University of Texas Health Science Center at TylerLead Sponsor

14 Previous Clinical Trials

25,488 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,388 Total Patients Enrolled

Frequently Asked Questions

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

Does this research encompass elderly participants?

"The minimum age for enrollment into this medical trial is 18, and the maximum allowable age is 64 as per its eligibility criteria."

Answered by AI

How many participants are included in this experiment?

"This medical trial has concluded recruitment, with the initial posting on July 1st 2021 and most recent update on May 4th 2021. However, those interested in participating in similar studies may find success as there are currently 105 trials for suicidal ideation and another 105 for Music that are still recruiting."

Answered by AI

Is enrollment for this trial still open to new participants?

"To enroll in this clinical trial, participants must have suicidal ideations and occupy the demographic range of 18-64 years old. Around 200 individuals are being sought for inclusion."

Answered by AI

Does the Food and Drug Administration grant authorization for Music as a therapeutic tool?

"Our team at Power gave Music a safety score of 2 owing to the fact that this Phase 2 trial has evidence indicating its safety, but no data verifying efficacy."

Answered by AI

Is this research still available to prospective participants?

"This trial is not presently enrolling patients. It was initially published on July 1st 2021 and the latest update occurred on May 4th, 2021. If you are in search of other studies, there are 105 trials for those with suicidal ideation and another 105 clinical tests related to music currently taking partcipants."

Answered by AI

Recent research and studies

American Journal of PsychiatryJournal

Acute and Longer-term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report

Rush, A. John, M.D., Madhukar H. Trivedi M.D., Stephen R. Wisniewski Ph.D., Andrew A. Nierenberg M.D., Jonathan W. Stewart M.D., Diane Warden Ph.D., M.B, George Niederehe Ph.D., et al.. 2006. “Acute and Longer-term Outcomes in Depressed Outpatients Requiring One or Several Treatment Steps: A STAR*D Report”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.2006.163.11.1905.

Biological PsychiatryJournal

Diagnosis and Definition of Treatment-resistant Depression

Fava, Maurizio. 2003. “Diagnosis and Definition of Treatment-resistant Depression”. Biological Psychiatry. Elsevier BV. doi:10.1016/s0006-3223(03)00231-2.

The Journal of Clinical PsychiatryJournal

Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-resistant Depression

Albott, C. Sophia, Kelvin O. Lim, Miriam K. Forbes, Christopher Erbes, Susanna J. Tye, John G. Grabowski, Paul Thuras, Tegan M. Batres-y-Carr, Joseph Wels, and Paulo R. Shiroma. 2018. “Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-resistant Depression”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.17m11634.

Biological PsychiatryJournal