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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
Must not have
Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses.
Treatment with a reversible MAOI within two weeks prior to Phase II.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up multiple

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.
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.
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.
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I agree to stay in the hospital if needed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Bipolar Disorder.
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I haven't taken any reversible MAOI drugs in the last two weeks.
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I do not have any serious, unstable illnesses affecting major body systems.
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I have not had seizures, epilepsy, stroke, brain surgery, head injury, or known brain issues.
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I have used opioid medication in the last 3 months.
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I have been diagnosed with hearing loss by a doctor.
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I am comfortable in small spaces and can lie still for up to 90 minutes.
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I weigh more than 119 kg.
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I am not a healthy volunteer for the ketamine metabolites study.
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I do not have any serious, unstable illnesses affecting my organs or immune system.
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I have had seizures with no known cause or I am on medication that may increase my risk of seizures.
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I am not taking any other medications.
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I have used opioid medication in the last 3 months.
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I weigh more than 119 kg.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
~1120

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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
2,918 Previous Clinical Trials
2,740,022 Total Patients Enrolled
701 Trials studying Depression
260,958 Patients Enrolled for Depression
Carlos A Zarate, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
15 Previous Clinical Trials
18,859 Total Patients Enrolled
13 Trials studying Depression
16,840 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
~2 spots leftby Jan 2025
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