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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

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.
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.
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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Ketamine
FDA approved
Esketamine
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,689 Total Patients Enrolled
193 Trials studying Depression
34,062 Patients Enrolled for Depression
American Foundation for Suicide PreventionOTHER
34 Previous Clinical Trials
9,742 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
~16 spots leftby Jun 2025