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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between weeks 0, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24
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 moreSecondary study objectives
Efficacy - Healthcare Utilization
Efficacy - Hospital Readmission Rates
Efficacy - Prevalence of Suicidal Behavior
+3 moreOther 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
3,010 Previous Clinical Trials
13,308,920 Total Patients Enrolled
191 Trials studying Depression
33,842 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing ECT treatment.I have a psychiatrist who has been treating me.I am in good health overall, based on recent medical exams and tests.I am currently having thoughts about harming myself.I am between 18 and 70 years old.I am currently taking high doses of medications like benzodiazepines or opiates.I have been treated with IV ketamine before.I have been diagnosed with Major Depressive Disorder and am currently in a depressive episode lasting at least 8 weeks.I have a history of bipolar disorder or have experienced psychotic symptoms during depression.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine and Esketamine Treatment
Awards:
This trial has 5 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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