RECRUITING

Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

Conditions

Major Depressive Disorder depression suicidal ideation

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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 study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.

Official Title

Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

Quick Facts

Study Start:2022-10-13

Study Completion:2025-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05450432

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 to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Inpatient at a psychiatric unit at MGH 2. Male and female, 18-70 years of age 3. Diagnosis of Major Depressive Disorder, single or recurrent, based on DSM-5 criteria, and currently experiencing a major depressive episode (MDE) at least eight weeks in duration, prior to screening 4. Current suicidal ideation 5. In good general health, as ascertained by medical history, physical examination, clinical laboratory evaluations, and/or ECG 6. A status of non-childbearing potential or use of an acceptable form of birth control 7. Access to a mobile phone or computer with internet connection 8. Ability to read, understand, and provide written and dated informed consent prior to screening 9. Has a treating psychiatrist, either prior to admission or at discharge from the inpatient unit	1. Any history of previous treatment with IV ketamine 2. Pregnant or breastfeeding 3. A status of childbearing potential and is not willing to use birth control during the study 4. Unstable medical illness 5. Current diagnosis of a moderate to severe substance use disorder, within the last six months prior to screening based on DSM-5 criteria 6. History of bipolar disorder, or any psychotic symptoms in the current or previous depressive episodes 7. An Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening (i.e., eating disorder, OCD, PTSD) 8. Currently receiving ECT treatment 9. Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, or other CNS depressant medications 10. Has dementia, delirium, amnestic, or any other primary cognitive disorder 11. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results 12. Inability to consent to or comply with the study procedures. 13. Other medical issues that might affect safety, study participation, or confound interpretation of study results 14. Inability to comply with study safety procedures, including having reliable escorts to and from visits

Inclusion Criteria

Exclusion Criteria

1. Inpatient at a psychiatric unit at MGH
2. Male and female, 18-70 years of age
3. Diagnosis of Major Depressive Disorder, single or recurrent, based on DSM-5 criteria, and currently experiencing a major depressive episode (MDE) at least eight weeks in duration, prior to screening
4. Current suicidal ideation
5. In good general health, as ascertained by medical history, physical examination, clinical laboratory evaluations, and/or ECG
6. A status of non-childbearing potential or use of an acceptable form of birth control
7. Access to a mobile phone or computer with internet connection
8. Ability to read, understand, and provide written and dated informed consent prior to screening
9. Has a treating psychiatrist, either prior to admission or at discharge from the inpatient unit

1. Any history of previous treatment with IV ketamine
2. Pregnant or breastfeeding
3. A status of childbearing potential and is not willing to use birth control during the study
4. Unstable medical illness
5. Current diagnosis of a moderate to severe substance use disorder, within the last six months prior to screening based on DSM-5 criteria
6. History of bipolar disorder, or any psychotic symptoms in the current or previous depressive episodes
7. An Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening (i.e., eating disorder, OCD, PTSD)
8. Currently receiving ECT treatment
9. Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, or other CNS depressant medications
10. Has dementia, delirium, amnestic, or any other primary cognitive disorder
11. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results
12. Inability to consent to or comply with the study procedures.
13. Other medical issues that might affect safety, study participation, or confound interpretation of study results
14. Inability to comply with study safety procedures, including having reliable escorts to and from visits

Contacts and Locations

Study Contact

Cristina Cusin, MD

CONTACT

617-724-5510

mghketamineclinic@mgh.harvard.edu

Julianne Origlio

CONTACT

617-643-2497

joriglio@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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 Date2022-10-13

Study Completion Date2025-06-01

Study Record Updates

Study Start Date2022-10-13

Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

depression
suicidal ideation

Additional Relevant MeSH Terms

Major Depressive Disorder