RECRUITING

PCORI Comparative Effectiveness Study-Esketamine (Spravato) Vs. Ketamine-Equivalence Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following: * How well the treatment helps with symptoms of depression (effectiveness), * How comfortable and willing people are to use the treatment (acceptability), and * How well people can deal with any side effects from the treatment (tolerability). The study will also examine factors that may predict which treatment works better for certain patients.

Official Title

Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression

Quick Facts

Study Start:2025-01-27

Study Completion:2030-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06713616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Adults ages 18 or older * Diagnosis of major depressive disorder that is refractory to two or more antidepressant trials * Moderate or severe depression based on an initial MADRS score ≥ 25 * Judged appropriate for ketamine or esketamine by clinician, independent of potential study participation * A female participant must be: * A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study \* We will consider women to be of childbearing potential if they are within 2 years of menopause (within 3 years since last menstrual period) and have not had a hysterectomy, bilateral oophorectomy, or other definitive surgical intervention.	* Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder) * Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis * Active or recent (within 12 months) substance use disorder (other than nicotine) * Pregnant or lactating women * Intracerebral hemorrhage or aneurysmal vascular disease * Hypersensitivity to ketamine, esketamine or any of the excipients * Known family history of ketamine use disorder * Prior known ketamine use disorder as well as subjects for whom study participations will result in more than 8 lifetime exposures to ketamine (e.g., prior exposure to ketamine, prior recreational use with ketamine) * Uncontrolled hypertension, as demonstrated by a blood pressure of greater than 145 / 90 at screening visit. (Pre-treatment blood pressure will be permitted to be 150 / 95 to allow for "whitecoat" hypertension on treatment visits 1-8.) * Known cardiovascular and cerebrovascular conditions that are associated with an increased risk related to ketamine or esketamine administration (including space-occupying CNS lesions). This includes those prospective participants who undergo EKG and are shown to have an abnormality that would put them at increased risk related to treatment. * Known condition for which an acute rise in blood pressure would pose a serious risk. * Arteriovenous malformation * Positive urine toxicology at screening visit, except for substances that are prescribed (i.e., benzodiazepines, stimulants). Given the extended length of time between exposure and negative toxicology screen, a positive screen for THC will not be exclusionary unless the pattern of use and clinical evaluation are indicative of cannabis use disorder. Cannabis used within 24 hours of dosing is exclusionary. * Positive alcohol breathalyzer at screening or clinical signs of intoxication * The patient is unable to arrange for someone to drive them home after each treatment session; patients who are unwilling to refrain from driving and operating machinery on treatment days until the next day following sleep will be excluded.

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Adults ages 18 or older
* Diagnosis of major depressive disorder that is refractory to two or more antidepressant trials
* Moderate or severe depression based on an initial MADRS score ≥ 25
* Judged appropriate for ketamine or esketamine by clinician, independent of potential study participation
* A female participant must be:
* A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study \* We will consider women to be of childbearing potential if they are within 2 years of menopause (within 3 years since last menstrual period) and have not had a hysterectomy, bilateral oophorectomy, or other definitive surgical intervention.

* Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)
* Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis
* Active or recent (within 12 months) substance use disorder (other than nicotine)
* Pregnant or lactating women
* Intracerebral hemorrhage or aneurysmal vascular disease
* Hypersensitivity to ketamine, esketamine or any of the excipients
* Known family history of ketamine use disorder
* Prior known ketamine use disorder as well as subjects for whom study participations will result in more than 8 lifetime exposures to ketamine (e.g., prior exposure to ketamine, prior recreational use with ketamine)
* Uncontrolled hypertension, as demonstrated by a blood pressure of greater than 145 / 90 at screening visit. (Pre-treatment blood pressure will be permitted to be 150 / 95 to allow for "whitecoat" hypertension on treatment visits 1-8.)
* Known cardiovascular and cerebrovascular conditions that are associated with an increased risk related to ketamine or esketamine administration (including space-occupying CNS lesions). This includes those prospective participants who undergo EKG and are shown to have an abnormality that would put them at increased risk related to treatment.
* Known condition for which an acute rise in blood pressure would pose a serious risk.
* Arteriovenous malformation
* Positive urine toxicology at screening visit, except for substances that are prescribed (i.e., benzodiazepines, stimulants). Given the extended length of time between exposure and negative toxicology screen, a positive screen for THC will not be exclusionary unless the pattern of use and clinical evaluation are indicative of cannabis use disorder. Cannabis used within 24 hours of dosing is exclusionary.
* Positive alcohol breathalyzer at screening or clinical signs of intoxication
* The patient is unable to arrange for someone to drive them home after each treatment session; patients who are unwilling to refrain from driving and operating machinery on treatment days until the next day following sleep will be excluded.

Contacts and Locations

Study Contact

Cindy Voghell

CONTACT

203-444-7115

Cynthia.Voghell@yale.edu

Kimberly Vasquez

CONTACT

212-363-0809

Kimberly.Vasquez@yale.edu

Principal Investigator

Samuel Wilkinson, MD

PRINCIPAL_INVESTIGATOR

Samuel.Wilkinson@yale.edu

Study Locations (Sites)

Yale School of Medicine

New Haven, Connecticut, 06512

United States

LifeStance Health

Moore, Oklahoma, 73160

United States

Houston Center for Advanced Psychiatric Treatment

Bellaire, Texas, 77401

United States

Collaborators and Investigators

Sponsor: Yale University

Samuel Wilkinson, MD, PRINCIPAL_INVESTIGATOR, Samuel.Wilkinson@yale.edu

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-27

Study Completion Date2030-12-31

Study Record Updates

Study Start Date2025-01-27

Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

Depression