Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Ketamine for Major Depressive Disorder

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.

Official registry: https://clinicaltrials.gov/study/NCT05450432 · Massachusetts General Hospital · enrollment listed as 100

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Ketamine, or Esketamine. The registry lists allocation as na. 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.

They plan to enroll about 100 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Ketamine, Esketamine

Primary outcome (registry wording): Feasibility - Retention

Who it is for (from inclusion criteria)

  • Ages 18 Years to 70 Years
  • Inpatient at a psychiatric unit (or MGH medical unit, awaiting transfer to psychiatry)
  • Male and female, 18-70 years of age, inclusive, at screening
  • Suicidal ideation determined by a minimum score of 1 on item 12 of the QIDS-C assessment and based on admission to the inpatient unit for suicidal thoughts or behaviors
  • In good general health, as ascertained by medical history. If needed to verify health status, the investigator may order/conduct physical examination (PE) (including measurement of supine and standing vital signs), clinical laboratory evaluations, or ECG
  • A status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:
  • Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test prior to receiving study treatment
  • 9\. Must have a provider to manage psychiatric medication, such as a psychiatrist, nurse practitioner, primary care physician, etc., either prior to admission or at discharge from the inpatient unit

Public study contact (from the registry)

Cristina Cusin, MD

617-724-5510

mghketamindstudy@partners.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT05450432 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05450432?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05450432?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary