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Intervention Group for Depression
Phase 4
Recruiting
Led By Deepan Singh, MD
Research Sponsored by Maimonides Medical Center
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 7 days
Awards & highlights
Study Summary
This trial will study if combining aspirin and ketamine can help treat people with depression that hasn't responded to other treatments.
Eligible Conditions
- Depression
- Peripheral Nervous System Agents
- Central Nervous System Depressants
- Sensory System Agents
- Nonsteroidal Anti-Inflammatory Drugs
- Non-Narcotic Analgesics
- Major Depressive Disorder
- Pain relief
- Ketamine
- Neurotransmitters
- Anti-Inflammatory Drugs
- Drug Effects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mental Depression
Secondary outcome measures
Mental Depression
Clinician-Administered Dissociative States Scale (CADSS)
Maximal sedative effects using Modified Observer's Assessment of Alertness and Sedation ( MOAA/S)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
All individuals 18 years old or older who have Major Depressive Disorder and have failed to achieve response or remission to at least one proven antidepressant trial with minimum affective dose for a duration of at least 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VTS-K
2021
N/A
~30
Find a Location
Who is running the clinical trial?
Maimonides Medical CenterLead Sponsor
69 Previous Clinical Trials
15,275 Total Patients Enrolled
Deepan Singh, MDPrincipal InvestigatorMaimonides Medical Center
4 Previous Clinical Trials
165 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a stomach ulcer that is causing symptoms.You have recently expressed thoughts of harming yourself or others.You are allergic to ketamine or aspirin.You are currently pregnant or breastfeeding.You have a history of bleeding in your digestive system, or your kidneys and liver are not working properly.You are currently struggling with drug or alcohol addiction.You currently have a severe mental health condition called psychosis that is not under control.You are taking lithium medication.You have trouble swallowing.You cannot have taken Aspirin or NSAIDs within 6 hours before coming to the site.You have been diagnosed with Major Depressive Disorder and have tried another type of antidepressant for at least 6 weeks but it did not improve your condition.You have a history of bipolar disorder, obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, or congestive heart failure.You have depression that only affects your mood in one direction (down).
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I satisfy the criteria to take part in this medical trial?
"A prerequisite to join this trial is having a sensory system and being within the parameters of 18 to 89 years old. 20 individuals are sought after for this clinical study."
Answered by AI
Is this investigation currently enrolling participants?
"According to the details found on clinicaltrials.gov, this trial is in need of participants and was originally published November 1st 2022 before being updated 8 days later."
Answered by AI
How many participants are currently enrolled in this experiment?
"Affirmative, according to the details available on clinicaltrials.gov, this study is still accepting applicants. Initial posting occurred November 1st 2022 with the last update being recorded on November 8th of that same year. A single medical centre needs to recruit 20 patients for this trial."
Answered by AI
Has this therapy gained regulatory clearance from the FDA?
"There is substantial evidence to suggest the safety of this treatment, which has been approved as part of a phase 4 trial; thus, granting it a score of 3."
Answered by AI
Are individuals below the age of 60 being included in this research experiment?
"This trial has set the eligibility bar for participants to be between 18 and 89 years old. Additionally, 206 studies are available for patients younger than 18 while 1066 specifically target seniors over 65."
Answered by AI
Who else is applying?
What site did they apply to?
Maimonides Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I've felt extremely stuck with depression. I've tried 3 different drugs, I exercise regularly, eat better than I ever have before, and generally follow a good sleep schedule, journaling, and lots more, but I still feel worthless and struggle to feel any motivation to engage in life. My brain feels so stuck in a deeply negative route and I'm hoping this trial could help kickstart my healing.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Maimonides Medical Center: < 48 hours
Average response time
- < 2 Days
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