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

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ClinicalTrials.gov Identifier: NCT05450432
Recruitment Status : Not yet recruiting
First Posted : July 8, 2022
Last Update Posted : July 8, 2022
Sponsor:
Collaborator:
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE June 16, 2022
First Posted Date  ICMJE July 8, 2022
Last Update Posted Date July 8, 2022
Estimated Study Start Date  ICMJE August 1, 2022
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2022)
  • Feasibility - Retention [ Time Frame: 24 weeks ]
    For examining the feasibility of treatment with ketamine and esketamine, descriptive analyses will be conducted to assess participants' retention across study visits.
  • Feasibility - Drop-out Rates [ Time Frame: 24 weeks ]
    For examining the feasibility of treatment with ketamine and esketamine, descriptive analyses will be conducted to assess participants' drop-out rates across participation in the study.
  • Tolerability - Cognitive Function and Side Effects [ Time Frame: Weeks 0, 1, 2, 3, 4, 8, and 12-24 ]
    In regard to tolerability, the investigators will closely monitor cognitive functions and side effects during the administration of ketamine and esketamine.
  • Tolerability - Dosage of Treatment [ Time Frame: Change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24 ]
    In regard to tolerability, the investigators will record the Necessary Clinical Adjustments (NCAs) for dosage of ketamine and esketamine treatments.
  • Tolerability - Frequency of Treatment [ Time Frame: Change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24 ]
    In regard to tolerability, the investigators will record the Necessary Clinical Adjustments (NCAs) for the frequency of ketamine and esketamine administration.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2022)
  • Efficacy - Treatment Response [ Time Frame: Weeks 4, 8, and 12-24 ]
    Descriptive analyses will be performed for percentage of responders (defined as 35% improvement on the QIDS-16) at the end of the IV ketamine acute phase, after the eighth ketamine infusion, and across the esketamine maintenance phase.
  • Efficacy - Trajectory of Suicidal Ideation [ Time Frame: 24 weeks ]
    The change in participants' suicidal ideation will be examined over time and compared to historical controls.
  • Efficacy - Trajectory of Depression [ Time Frame: 24 weeks ]
    The change in participants' depression will be examined over time and compared to historical controls.
  • Efficacy - Hospital Readmission Rates [ Time Frame: 24 weeks ]
    The change in participants' hospital readmission rates will be examined over time and compared to historical controls.
  • Efficacy - Prevalence of Suicidal Behavior [ Time Frame: 24 weeks ]
    The occurrence of suicidal behavior (gestures, attempts, and completed suicide) among participants will be examined over time and compared to historical controls.
  • Efficacy - Healthcare Utilization [ Time Frame: 24 weeks ]
    The change in participants' healthcare utilization rates will be examined over time and compared to historical controls.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 5, 2022)
  • Exploratory Aim - Predictors of Treatment Response [ Time Frame: 24 weeks ]
    Exploratory aims will be examined, including predictors of treatment response (defined as 35% improvement in QIDS score) at the end of the acute and maintenance phases.
  • Exploratory Aim - Predictors of Suicidal Ideation Relapse [ Time Frame: 24 weeks ]
    Exploratory aims will be examined, including predictors of suicidal ideation relapse (defined as SSI5>1) during time intervals between intravenous ketamine visits and during the esketamine maintenance phase.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
Official Title  ICMJE Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Ketamine and Esketamine Treatment
All study subjects will receive intravenous (IV) ketamine and intranasal (IN) esketamine treatment.
Interventions:
  • Drug: Ketamine
  • Drug: Esketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2022)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2025
Estimated Primary Completion Date June 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cristina Cusin, MD 617-724-5510 mghketamineclinic@mgh.harvard.edu
Contact: Julianne Origlio 617-643-2497 joriglio@mgh.harvard.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05450432
Other Study ID Numbers  ICMJE 2022P000972
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The investigators do not plan to share IPD.
Current Responsible Party Cristina Cusin, MD, Massachusetts General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Massachusetts General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE American Foundation for Suicide Prevention
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP