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NMDA Receptor Antagonist
Ketamine Imaging for Mood Disorders
N/A
Recruiting
Led By Irina Esterlis, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects undergoing ketamine treatment must meet DSM-5 diagnostic criteria for Major Depressive Disorder and for a current depressive episode as assessed by structured interview for DSM-5 diagnosis (SCID) and be undergoing ketamine treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion date, an average of 5 years.
Awards & highlights
Study Summary
This trial is designed to study the effects of ketamine on synaptic density in people with depression or PTSD.
Who is the study for?
This trial is for adults aged 18-70 with Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), who understand the study's research nature. Healthy individuals without any DSM-5 diagnosis can also participate. Exclusions include neurological issues, low IQ, substance abuse, certain medical conditions, and contraindications to MRI or PET scans like claustrophobia.Check my eligibility
What is being tested?
The study investigates how ketamine affects synaptic density in people with MDD and PTSD using imaging techniques like MRI and PET scans. Participants will undergo cognitive tests and a stress test on scan days to see if ketamine can reverse changes associated with these disorders.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of ketamine may include confusion, hallucinations, changes in blood pressure, dizziness, nausea, and blurred vision during the short-term post-administration period.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with Major Depressive Disorder and currently receiving ketamine treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion date, an average of 5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion date, an average of 5 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evidence of synaptic changes in psychiatric disorders confirmed by PET data.
Evidence of synaptic density at time of its greatest anti-depressant response in psychiatric disorders confirmed with PET data.
Trial Design
3Treatment groups
Active Control
Group I: PET scans for subjects undergoing ketamine treatmentActive Control1 Intervention
For subjects currently undergoing treatment with ketamine. Subjects will participate in 1-3 PET scans (up to 4 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan. Baseline scan will occur prior to initiation of ketamine treatment. Subsequent scans will occur after several treatments with ketamine and after completion of treatment.
Bipolar subjects will not participate in any ketamine arms.
Group II: PET scans and ketamine administrationActive Control1 Intervention
Subjects will participate in 2-3 PET scans (up to 4 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan. After a baseline scan, subjects will be administered a low dose of ketamine for the second scan.
Bipolar subjects will not participate in any ketamine arms.
Group III: Single PET scanActive Control1 Intervention
Subjects will participate in 1 PET scan (up to 2 if cancelations occur) on the High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or the HR+ will be used to image subjects. Vital signs (blood pressure and pulse) will be obtained before and after radiotracer administration. Venous catheter(s) will be used for IV administration of the radiotracer and for venous blood sampling. An arterial catheter will be inserted by an experienced physician before the PET scan.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentFED
1,609 Previous Clinical Trials
3,306,299 Total Patients Enrolled
77 Trials studying Depression
20,689 Patients Enrolled for Depression
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,688 Total Patients Enrolled
64 Trials studying Depression
20,646 Patients Enrolled for Depression
Irina Esterlis, PhDPrincipal Investigator - Yale School of Medicine
Yale University
3 Previous Clinical Trials
349 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old.You understand that this study is solely for research purposes and not for medical treatment.You do not have any current or past mental health conditions as defined by the DSM-5.I have been diagnosed with bipolar disorder according to DSM-5.I have never had a major brain condition, injury, or long-term memory loss.I cannot have a PET scan due to past cancer or issues with my veins.I have been diagnosed with major depression or PTSD with psychotic features.I weigh less than 110 lbs.I am currently diagnosed with PTSD.I am between 18 and 70 years old, speak English, and have no mental health diagnoses except as specified.I am diagnosed with Major Depressive Disorder and currently receiving ketamine treatment.You do not have any other mental health conditions, except for the ones listed below.I am currently diagnosed with PTSD.I have a bleeding disorder or am currently on blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: PET scans for subjects undergoing ketamine treatment
- Group 2: PET scans and ketamine administration
- Group 3: Single PET scan
Awards:
This trial has 1 awards, including:- 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.
Depression Patient Testimony for trial: Trial Name: NCT02734602 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is enrollment being pursued for this clinical trial?
"Affirmative. Clinicaltrials.gov has evidence that this medical investigation, which was first publicized on April 1st 2016, is currently recruiting members for the trial. 30 patients must be enrolled from a single study site."
Answered by AI
Who meets the eligibility criteria to be involved in this clinical trial?
"This medical experiment is looking for 30 individuals with a diagnosis of mood disorder between the ages 18 and 70. Notably, applicants must have no current or past DSM-5 disorders, be treatment seeking aware that this study serves research purposes only and possess a Post Traumatic Stress Disorder (PTSD)."
Answered by AI
Are there any vacancies in this clinical trial for participants?
"Clinicaltrials.gov indicates that this clinical trial is in the recruitment phase, which it entered when first posted on April 1st 2016 and was most recently updated on April 13th 2022."
Answered by AI
Does the age of 50 constitute a barrier to entry for this experiment?
"The requirements for patient inclusion in this trial are 18 years of age as the lower limit and 70 as the upper age limit."
Answered by AI
Who else is applying?
What state do they live in?
Florida
New York
Connecticut
How old are they?
18 - 65
What site did they apply to?
PET Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
What questions have other patients asked about this trial?
What are you going to do to me? Do I have to live in or near New Haven to do this study? Is it a daily IV or tablet form?
PatientReceived no prior treatments
Why did patients apply to this trial?
I’ve heard a lot about keta. I need help plain and simple! I've tried 7 drugs with no help.
PatientReceived 2+ prior treatments
I want my life back. Trauma therapy is not working. I have tried many meds and none have worked well. I have suffered from depression for most of my life.
PatientReceived 2+ prior treatments
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