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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: American Foundation for Suicide Prevention
• Treatments: Esketamine; Ketamine

Criteria

Inclusion Criteria:

1. Inpatient at a psychiatric unit at MGH

2. Male and female, 18-65 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. Owner of a mobile phone with cellular data

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

Exclusion Criteria:

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