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NMDA Receptor Antagonist

Ketamine + Esketamine for Depression

Phase 4
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24
Awards & highlights

Study Summary

This trialwill examine outcomes of patients with depression and suicidal ideation who receive IV ketamine & IN esketamine compared to a historical group. Patients will get 8 IV ketamine treatments, 13 esketamine visits & daily surveys. It will look at feasibility, tolerability & efficacy of the treatment.

Who is the study for?
This trial is for adults aged 18-70 with Major Depressive Disorder and suicidal thoughts, who are inpatients at a psychiatric unit. They must be in good health, not pregnant or breastfeeding, willing to use birth control if applicable, have internet access and a treating psychiatrist. Excluded are those on certain CNS depressants or with recent substance abuse issues.Check my eligibility
What is being tested?
The study tests the effects of IV ketamine followed by IN esketamine over 24 weeks against historical controls for reducing suicide risk in depression patients. It includes multiple treatment sessions, assessments visits, and daily surveys to evaluate feasibility, tolerability and predictors of response.See study design
What are the potential side effects?
While not explicitly listed here, common side effects from ketamine/esketamine may include dissociation (feeling disconnected), dizziness, nausea, sedation (sleepiness), increased blood pressure, euphoria (intense happiness), and potential for misuse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility - Drop-out Rates
Feasibility - Retention
Tolerability - Cognitive Function and Side Effects
+2 more
Secondary outcome measures
Efficacy - Healthcare Utilization
Efficacy - Hospital Readmission Rates
Efficacy - Prevalence of Suicidal Behavior
+3 more
Other outcome measures
Exploratory Aim - Predictors of Suicidal Ideation Relapse
Exploratory Aim - Predictors of Treatment Response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ketamine and Esketamine TreatmentExperimental Treatment2 Interventions
All study subjects will receive intravenous (IV) ketamine and intranasal (IN) esketamine treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esketamine
FDA approved
Ketamine
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,541 Total Patients Enrolled
184 Trials studying Depression
29,456 Patients Enrolled for Depression
American Foundation for Suicide PreventionOTHER
33 Previous Clinical Trials
9,675 Total Patients Enrolled
9 Trials studying Depression
5,752 Patients Enrolled for Depression

Media Library

Esketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05450432 — Phase 4
Depression Research Study Groups: Ketamine and Esketamine Treatment
Depression Clinical Trial 2023: Esketamine Highlights & Side Effects. Trial Name: NCT05450432 — Phase 4
Esketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05450432 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical study actively seeking new volunteers?

"According to the clinicaltrials.gov website, this medical trial is still enrolling participants and has been updated as recently as January 20th, 2021. It was initially posted on October 13th 2022."

Answered by AI

Is this therapeutic intervention formally recognized by the FDA?

"Given that this is a Phase 4 trial, the Power team assigned it an optimistic safety rating of 3 due to its official approval status."

Answered by AI

What are the major goals of this clinical endeavor?

"This medical trial, which will be observed for roughly 24 weeks, seeks to assess the tolerability of various dosages. Secondary objectives encompass assessing changes in depression symptoms and hospital readmission rates versus historic controls as well as gauging the prevalence of suicidal behavior among participants over time."

Answered by AI

Is this clinical investigation open to participants over a certain age threshold?

"The parameters of this medical study necessitate that qualified applicants are between 18 and 70 years old. Of note, there are 263 studies specifically targeting individuals younger than 18 and 1113 for seniors over 65."

Answered by AI

How many individuals are participating in this experiment?

"Affirmative, the information provided on clinicaltrials.gov supports that this experiment is actively searching for research subjects. This trial was incepted on October 13th 2022 and revised lastly on January 20th 2023. A total of 100 participants are needed across 1 medical facility."

Answered by AI

Who can qualify to partake in this investigation?

"This clinical trial seeks to recruit 100 people living with depression aged between 18 and 70. Those interested must display current suicidal thoughts, be diagnosed with Major Depressive Disorder in line with the DSM-5 criteria, and have experienced an MDE for at least two months prior to screening. Additionally, participants should possess a mobile device or computer capable of connecting to the internet."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried 3 previous drugs and 2 current drugs which are not controlling my depression and suicidal ideation.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
Cristina Cusin, MD 2022. "Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05450432.
All > Depression Boston > Spravato
~42 spots leftby Jun 2025
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