Clinical trial NCT05450432: Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
Official title: Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: depression
suicidal ideation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2022-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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 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

Primary outcomes:
measure: Feasibility - Retention
timeFrame: 24 weeks
measure: Feasibility - Drop-out Rates
timeFrame: 24 weeks
measure: Tolerability - Cognitive Function and Side Effects
timeFrame: Weeks 0, 1, 2, 3, 4, 8, and 12-24
measure: Tolerability - Dosage of Treatment
timeFrame: Change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24
measure: Tolerability - Frequency of Treatment
timeFrame: Change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24
Secondary outcomes:
measure: Efficacy - Treatment Response
timeFrame: Weeks 4, 8, and 12-24
measure: Efficacy - Trajectory of Suicidal Ideation
timeFrame: 24 weeks
measure: Efficacy - Trajectory of Depression
timeFrame: 24 weeks
measure: Efficacy - Hospital Readmission Rates
timeFrame: 24 weeks
measure: Efficacy - Prevalence of Suicidal Behavior
timeFrame: 24 weeks
measure: Efficacy - Healthcare Utilization
timeFrame: 24 weeks
Other outcomes:
measure: Exploratory Aim - Predictors of Treatment Response
timeFrame: 24 weeks
measure: Exploratory Aim - Predictors of Suicidal Ideation Relapse
timeFrame: 24 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: