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NMDA Receptor Antagonist

Ketamine for Major Depressive Disorder

Phase 1
Recruiting
Led By Carlos A Zarate, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 to 65 years of age.
Agree to be hospitalized
Timeline
Screening 3 weeks
Treatment Varies
Follow Up multiple
Awards & highlights

Study Summary

This trial is studying how ketamine affects the brain by looking at metabolites, which are created when a drug is broken down.

Who is the study for?
Adults aged 18-65 with major depressive disorder currently experiencing a depressive episode, and healthy volunteers. Participants must understand the study procedures and consent to them, have no bipolar or psychotic disorders, no recent substance abuse (except caffeine/nicotine), not be at serious suicide/homicide risk, not pregnant or nursing, and without unstable illnesses.Check my eligibility
What is being tested?
The trial is testing the rapid antidepressant effects of ketamine infusions compared to placebo in treating depression. It includes MRI scans during treatment phases and optional extended monitoring. A substudy examines how ketamine affects brain chemistry through cerebrospinal fluid analysis after spinal taps.See study design
What are the potential side effects?
Possible side effects from ketamine may include dissociation, dizziness, nausea, increased blood pressure, euphoria during infusion; long-term use could potentially lead to cognitive changes or bladder issues. The procedure-related risks involve discomfort from MRI scans or potential complications from spinal taps.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I agree to stay in the hospital if needed.
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I have been diagnosed with major depression and am currently experiencing an episode lasting at least 2 weeks.
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My depression score is 20 or higher and my mania score is below 12.
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I am between 18 and 65 years old.
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I agree to stay in the hospital if needed.
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I have been diagnosed with major depression and am currently experiencing an episode lasting at least 2 weeks.
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My depression score is 20 or higher and my mania score is below 12.
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I have depression that didn't improve after trying at least one antidepressant or ECT.
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I am a healthy volunteer.
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I am between 18 and 65 years old.
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I agree to stay in the hospital if needed.
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I am between 18 and 65 years old.
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I have been diagnosed with major depression and am currently experiencing an episode lasting at least 2 weeks.
Select...
I am between 18 and 65 years old.
Select...
I agree to stay in the hospital if needed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~multiple
This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ketamine Metabolites Substudy: To determine if ketamine metabolites cross the blood brain barrier and enter the brain during ketamine IV administration.
To demonstrate more robust neuropharmacodynamic effects measured by neuropharmacodynamic imaging (fMRI+EEG and MEG) of ketamine 0.5 mg/kg as compared to placebo administered over 40 minutes.
Secondary outcome measures
Ketamine Metabolites Substudy: To correlate metabolite levels in periphery and CSF with changes in clinical rating scales.
To demonstrate enhanced efficacy, as measured by the MADRS, of IV ketamine 0.5 mg/kg in participants with MDD using a psychophysiological technique (i.e. NPU-threat test).
To determine if increases in synaptic plasticity, using electrophysiological measures in response to TMS and in association with sleep (i.e. slow wave sleep EEG activity) are associated with better antidepressant response to 0.5 mg/kg ketamine.
+2 more

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Phase IIIExperimental Treatment3 Interventions
Double-blind, repeated dose of 0.5 mg/kg or 0.1 mg/kg IV ketamine
Group II: Phase II, Arm 1bExperimental Treatment3 Interventions
Double-blind, single dose of 0.5 mg/kg IV ketamine, concurrently with fMRI+EEG or MEG
Group III: Phase II, Arm 1Experimental Treatment3 Interventions
Double-blind, single dose of 0.5 mg/kg IV ketamine
Group IV: Phase IExperimental Treatment1 Intervention
Medication taper, drug-free period, and baseline assessments
Group V: Metabolites SubstudyExperimental Treatment3 Interventions
Open-label, single dose of 0.5 mg/kg IV ketamine
Group VI: Phase IVActive Control1 Intervention
Follow-up evaluations
Group VII: Phase II, Arm 2Placebo Group3 Interventions
Double-blind, single dose of 0.5 mg/kg IV saline
Group VIII: Phase II, Arm 2bPlacebo Group3 Interventions
Double-blind, single dose of 0.5 mg/kg IV saline, concurrently with fMRI+EEG or MEG.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,784 Previous Clinical Trials
2,689,127 Total Patients Enrolled
666 Trials studying Depression
251,434 Patients Enrolled for Depression
Carlos A Zarate, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
14 Previous Clinical Trials
17,199 Total Patients Enrolled
12 Trials studying Depression
16,804 Patients Enrolled for Depression

Media Library

Ketamine (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03065335 — Phase 1
Depression Research Study Groups: Metabolites Substudy, Phase I, Phase II, Arm 1, Phase II, Arm 1b, Phase II, Arm 2, Phase II, Arm 2b, Phase III, Phase IV
Depression Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT03065335 — Phase 1
Ketamine (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03065335 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned Ketamine for therapeutic use?

"Due to the limited amount of safety data available, Ketamine was given a score of 1 on our team's risk assessment scale. This Phase 1 trial has minimal evidence regarding efficacy or safety."

Answered by AI

Does the age of 65 and over disqualify someone from participating in this experiment?

"The criteria for inclusion in this trial necessitates that potential participants are aged 18 to 65 years old. For those underage or above the specified age, 465 and 1902 trials respectively exist as alternatives."

Answered by AI

What are the key aims of this clinical investigation?

"This multi-faceted trial will assess the efficacy of ketamine administration over multiple time frames. Primary outcomes include determining if active metabolites cross the blood brain barrier and enter the brain, as well as a correlation between synaptic plasticity, TMS responses, slow wave sleep EEG activity, and antidepressant response. Secondary objectives involve correlating metabolite levels in periphery and CSF with changes in clinical rating scales; identifying baseline peripheral measures associated with response to 0.5 mg/kg ketamine administration; and using plasma/serum biomarkers as potential acute (24 hour) treatment response indicators."

Answered by AI

What is the maximum number of participants involved in this clinical experiment?

"Indeed, the clinicaltrials.gov website indicates that this trial is actively enrolling participants. It was initially published on May 25th 2017 and has since been updated as recently as November 4th 2022. This experiment seeks to recruit 150 people from a single location."

Answered by AI

May I join this experimental research project?

"Aspiring participants in this clinical trial must have a diagnosis of Major Depressive Disorder (MDD) with symptoms lasting for at least two weeks, be between 18 and 65 years old, agree to hospitalisation, and pass the screening assessments from either Protocol 01-M-0254 or 17-M-0181. Additionally, they must score greater than 20 on the MADRS scale and less than 12 on YMRS during initial screenings as well as beginning Phases II and III. A total of 150 people will be admitted into the study."

Answered by AI

Are there any vacancies in this research program for individuals to partake?

"Correct. According to records on clinicaltrials.gov, this research is currently searching for 150 patients from a single location. This project was first posted on May 25th 2017 and the most recent update occurred November 4th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
65+
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried different medications and nothing has helped.
PatientReceived no prior treatments
Recent research and studies
Translational PsychiatryJournal
Comparative Metabolomic Analysis in Plasma and Cerebrospinal Fluid of Humans and in Plasma and Brain of Mice Following Antidepressant-dose Ketamine Administration
Moaddel, Ruin, Panos Zanos, Cristan A. Farmer, Bashkim Kadriu, Patrick J. Morris, Jacqueline Lovett, Elia E. Acevedo-Diaz, et al.. 2022. “Comparative Metabolomic Analysis in Plasma and Cerebrospinal Fluid of Humans and in Plasma and Brain of Mice Following Antidepressant-dose Ketamine Administration”. Translational Psychiatry. Springer Science and Business Media LLC. doi:10.1038/s41398-022-01941-x.
clinicaltrials.govStudy
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
2017. "Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03065335.
All > Mdd > Treatment Resistant Depression
~13 spots leftby Jan 2025
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