Clinical TrialMajor Depressive Disorder (MDD)KetamineEsketamineRecruiting

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

This interventional trial (n=100) aims to investigate the long-term maintenance effects of ketamine and esketamine on reducing suicide risk in patients with Major Depressive Disorder (MDD) and suicidal ideation (SI).

Target Enrollment
100 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

This 24-week single-group treatment trial enrolls inpatients with MDD and current suicidal ideation to receive an acute course of up to eight IV ketamine infusions followed by maintenance intranasal esketamine (13 treatments). Participants are compared with matched historical controls identified from electronic medical records.

Outcomes include feasibility, tolerability, and efficacy for suicide-risk reduction and depressive symptoms, as well as predictors of response; assessments include seven long visits, five short visits, and daily surveys.

Study Protocol

Preparation

sessions

Dosing

21 sessions

Integration

sessions

Study Arms & Interventions

Ketamine + Esketamine

experimental

All participants receive acute IV ketamine infusions then transition to maintenance intranasal esketamine; single-group intervention compared to matched historical controls.

Interventions

  • Ketamine
    via IV• two per week during acute phase• 8 doses total

    Up to eight IV ketamine infusions (two per week during acute phase).

  • Esketamine
    via Other• weekly• 13 doses total

    Intranasal esketamine (Spravato) initiated ~1 month after 8th infusion per REMS protocol; 13 treatments over maintenance phase.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • 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 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

Exclusion Criteria

  • 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
  • 14. Inability to comply with study safety procedures, including having reliable escorts to and from visits

Study Details

Locations

Massachusetts General Hospital — Boston, Massachusetts, United States

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