RecruitingPhase 4NCT05450432

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

Sponsor

Massachusetts General Hospital

Enrollment

100 participants

Start Date

Oct 13, 2022

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether ongoing treatment with ketamine or esketamine (a fast-acting antidepressant given as an infusion or nasal spray) can reduce suicidal thoughts and behaviors over the long term in people who are at high risk for suicide. **You may be eligible if...** - You are an adult with a history of suicidal thoughts or attempts - You are currently experiencing high suicide risk - You have not responded well to standard antidepressant treatments - You are able to receive ongoing monitoring and follow-up **You may NOT be eligible if...** - You have a history of psychosis or a schizophrenia-spectrum disorder - You have active untreated substance use disorder - You have heart conditions that make ketamine unsafe - You are pregnant or breastfeeding - You are unable to commit to regular clinic visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine

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.

DRUGEsketamine

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.