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NMDA Receptor Antagonist
Ketamine for Depression
Phase < 1
Recruiting
Led By Michael Treadway, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
men or women, 18-65 years of age
MDD Patients: primary diagnosis of DSM (Diagnostic and Statistical Manual of Mental Disorders)-V MDD, current, as diagnosed by the SCID-I (Structured Clinical Interview for DSM Disorders)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 hours post-infusion, 14 days post-infusion
Awards & highlights
Study Summary
This trial will study how ketamine affects decision-making and emotion processing in people with Major Depressive Disorder.
Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) and moderate to very severe depression, as indicated by a score of ≥20 on the Beck Depression Inventory. Participants must not have used antidepressants for at least 8 weeks before starting the study. Exclusions include treatment-resistant MDD, adverse reactions to ketamine, certain physical illnesses, substance abuse within the last 6 months, active suicidal thoughts, or pregnancy.Check my eligibility
What is being tested?
The study tests how ketamine affects decision-making and emotion in people with MDD compared to a placebo. It aims to understand if changes in brain function related to stress and pleasure are influenced by ketamine administration.See study design
What are the potential side effects?
Ketamine may cause side effects such as disorientation, dizziness, nausea, elevated blood pressure during infusion, dissociation (feeling disconnected from reality), mood swings or unusual behavior.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I have been diagnosed with major depression according to the DSM-V.
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I have been diagnosed with major depression.
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I am between 18 and 65 years old.
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I am between 18 and 65 years old and have major depressive disorder.
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I haven't taken any antidepressants for at least 8 weeks.
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I haven't taken any antidepressants for at least 8 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 24 hours post-infusion, 14 days post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24 hours post-infusion, 14 days post-infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in glutamate concentration in the medial prefrontal cortex (mPFC)
Other outcome measures
Apathy
Change in Apathy Motivation Index (AMI)
Change in Digit Symbol Task (DST)
+13 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Major depressive disorder (MDD) KetamineExperimental Treatment1 Intervention
Participants randomized to the ketamine arm will receive a single intravenous (IV) infusion of ketamine at 0.5mg/kg through an indwelling catheter over a 40-100min period.
Group II: Healthy ControlsActive Control1 Intervention
The subjects in this group will not receive any intervention.
Group III: Major depressive disorder (MDD) PlaceboPlacebo Group1 Intervention
Participants randomized to the placebo arm will receive a single intravenous (IV) infusion of saline through an indwelling catheter over a 40-100min period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,642 Previous Clinical Trials
2,563,756 Total Patients Enrolled
60 Trials studying Depression
9,016 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,795 Previous Clinical Trials
2,688,976 Total Patients Enrolled
670 Trials studying Depression
252,648 Patients Enrolled for Depression
Michael Treadway, PhDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
242 Total Patients Enrolled
2 Trials studying Depression
242 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a score of 20 or higher on the Beck Depression Inventory, which means you have moderate to very severe depressive symptoms.Your MMSE score is less than 28.If you have had problems with drugs or alcohol in the past 6 months, you cannot participate.I am between 18 and 65 years old.I have been diagnosed with major depression according to the DSM-V.I have been diagnosed with major depression.I am using or will use glucocorticoids during the study.If you have strong thoughts about hurting yourself, you cannot participate in the study.I am not using glucocorticoids during the study.I have Raynaud's disease that affects my reaction to cold.If you have had a bad reaction to ketamine in the past, you cannot participate.Healthy participants should not have any psychiatric disorders, except for specific phobias. They should not have a history of any psychiatric disorders, except for mild past substance use disorder.I take more than 2mg of lorazepam or a similar drug daily for depression.I do not have unstable heart, liver, kidney, blood, hormone disorders, breathing problems, glaucoma, or porphyria.I have no health issues that prevent me from having an MRI.I cannot have an MRI due to certain health reasons.If you have major depressive disorder, your Mini-Mental State Exam score is less than 28.My blood pressure is high, with systolic over 160 or diastolic over 100.If you have used drugs or alcohol excessively in the past 6 months, you cannot participate as a healthy control.I am between 18 and 65 years old and healthy.I am between 18 and 65 years old.You have a history of not responding well to antidepressant treatment.I am between 18 and 65 years old and have major depressive disorder.I have Raynaud's disease that could affect cold sensitivity tests.You have a history of bipolar disorder or psychotic disorder.If you have active hallucinations or delusions, you cannot participate in the study.I haven't taken any antidepressants for at least 8 weeks.I am taking antipsychotic medications for my depression.If you use recreational drugs, it will show up in a urine test.Women who are pregnant or breastfeeding cannot participate as healthy controls.You have a high score on a test for depression, indicating moderate to very severe symptoms.I haven't taken any antidepressants for at least 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Major depressive disorder (MDD) Ketamine
- Group 2: Major depressive disorder (MDD) Placebo
- Group 3: Healthy Controls
Awards:
This trial has 0 awards, including: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.
Depression Patient Testimony for trial: Trial Name: NCT05327699 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still room available for participants in this experiment?
"Clinicaltrials.gov confirms that this medical trial is presently recruiting participants, with the first post appearing on September 1st 2022 and the most recent update posted on September 23rd 2022."
Answered by AI
What is the current sample size of participants in this medical experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical investigation is actively searching for participants; it was published on September 1st 2022 and last updated a month later. 250 patients from one research location are needed in order to proceed with the study."
Answered by AI
Is participation in this clinical experiment available to me?
"This medical study is accepting applicants aged 18-65 who have been diagnosed with psychosis and involutional depression. In addition to meeting these criteria, prospects must be able to provide written informed consent, have a Beck Depression Inventory score of at least 20 (which denotes moderate/severe or very severe depressive symptoms), demonstrate a DSM V Major Depressive Disorder diagnosis through the SCID-I Structured Clinical Interview process, and abstain from antidepressant use for 8 weeks prior to enrollment."
Answered by AI
Does this clinical exploration accept participants of greater than twenty-five years old?
"The requisite age range for inclusion in this clinical trial is 18 to 65, as specified by the study's criteria."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
California
Georgia
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
3+
What site did they apply to?
Emory University
What questions have other patients asked about this trial?
Is there certain medications I am prescribed that would illuminate me as trial candidate?
PatientReceived no prior treatments
Why did patients apply to this trial?
To help my depression. I’ve tried many antidepressants and nothing has ever worked for me.
PatientReceived 1 prior treatment
I’ve had TRD since I was 8 years old. The only med that semi worked was Abilify as an add on to lexapro and that gave me TD. I’m at my wits end. I just want quality of life!
PatientReceived no prior treatments
Have been being prescribed so many medication from my VA therapist that we have went back to retry those they kind of helped but not enough to achieve a quality of life. So was researching trials and one came up for my Muskogee VA so applied.
PatientReceived no prior treatments
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