Last updated: January 20, 2023
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Suicide
Depression
Depression (Major/severe)
Treatment
N/AClinical Study ID
NCT05450432
2022P000972
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Inpatient at a psychiatric unit at MGH
- Male and female, 18-70 years of age
- 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
- Current suicidal ideation
- In good general health, as ascertained by medical history, physical examination,clinical laboratory evaluations, and/or ECG
- A status of non-childbearing potential or use of an acceptable form of birth control
- Access to a mobile phone or computer with internet connection
- Ability to read, understand, and provide written and dated informed consent prior toscreening
- Has a treating psychiatrist, either prior to admission or at discharge from theinpatient unit
Exclusion
Exclusion Criteria:
- Any history of previous treatment with IV ketamine
- Pregnant or breastfeeding
- A status of childbearing potential and is not willing to use birth control during thestudy
- Unstable medical illness
- Current diagnosis of a moderate to severe substance use disorder, within the last sixmonths prior to screening based on DSM-5 criteria
- History of bipolar disorder, or any psychotic symptoms in the current or previousdepressive episodes
- 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)
- Currently receiving ECT treatment
- Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, orother CNS depressant medications
- Has dementia, delirium, amnestic, or any other primary cognitive disorder
- Has a clinically significant abnormality on the screening physical examination thatmight affect safety, study participation, or confound interpretation of study results
- Inability to consent to or comply with the study procedures.
- Other medical issues that might affect safety, study participation, or confoundinterpretation of study results
- 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 StatesActive - Recruiting

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