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

Last updated: January 20, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Suicide

Depression

Depression (Major/severe)

Treatment

N/A

Clinical Study ID

NCT05450432
2022P000972
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion 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 induration, 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 toscreening
  9. Has a treating psychiatrist, either prior to admission or at discharge from theinpatient unit

Exclusion

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 thestudy
  4. Unstable medical illness
  5. Current diagnosis of a moderate to severe substance use disorder, within the last sixmonths prior to screening based on DSM-5 criteria
  6. History of bipolar disorder, or any psychotic symptoms in the current or previousdepressive episodes
  7. An Axis I or Axis II Disorder, which at screening is clinically predominant to theirMDD or has been predominant to their MDD at any time within six months prior toscreening (i.e., eating disorder, OCD, PTSD)
  8. Currently receiving ECT treatment
  9. Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, orother 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 thatmight 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 confoundinterpretation of study results
  14. Inability to comply with study safety procedures, including having reliable escorts toand from visits

Study Design

Total Participants: 100
Study Start date:
October 13, 2022
Estimated Completion Date:
June 01, 2025

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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