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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

  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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
A total of 100 participants will be enrolled in the study to receive intravenous ketamine and intranasal esketamine. Participants will be compared against matched historical control subjects identified through electronic medical records.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Ketamine and Esketamine Treatment 		All study subjects will receive intravenous (IV) ketamine and intranasal (IN) esketamine treatment.
  • Drug: Ketamine
    Study participants will start treatment including two ketamine infusion visits per week during the acute phase, for up to eight ketamine infusion visits. Participants will then be transitioned to maintenance with intranasal esketamine.
  • Drug: Esketamine
    After one month from the eighth ketamine infusion visit, participants will initiate weekly esketamine for 12 weeks, for a total of 13 esketamine treatments. The esketamine visits will happen as per standard of care at the clinic and as instructed by the SPRAVATO Risk Evaluation and Mitigation Strategy.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Julianne Origlio
617-643-2497

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Cristina Cusin, MD
617-724-5510
mghketamineclinic@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.