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Esketamine vs Aripiprazole for Treatment-Resistant Depression (VAST-D II Trial)
Phase 4
Waitlist Available
Led By Somaia Mohamed, PhD
Research Sponsored by VA Office of Research and Development
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 6 weeks
Awards & highlights
VAST-D II Trial Summary
This trial is testing whether intranasal esketamine is more effective than aripiprazole for treating veterans with unipolar treatment-resistant depression.
Who is the study for?
This trial is for Veterans aged 18-74 with Treatment Resistant Depression, having tried at least two antidepressants without success. Participants must be on a stable antidepressant dose for six weeks prior to the study and have a QIDS-C16 score over 14. Exclusions include cognitive dysfunction, recent substance abuse (except cannabis, tobacco, caffeine), uncontrolled hypertension, significant cardiovascular disease, unstable medical conditions, pregnancy or unwillingness to use contraception.Check my eligibility
What is being tested?
The trial compares intranasal esketamine (ESK) versus adjunctive aripiprazole (ARI) in treating depression that hasn't improved with standard treatments. It's an open-label study where participants know which treatment they receive and aims to see if ESK leads to higher remission rates after six weeks compared to ARI.See study design
What are the potential side effects?
Esketamine may cause dissociation, dizziness, nausea, sedation or blood pressure increases; while Aripiprazole can lead to restlessness, weight gain or metabolic changes like increased sugar levels. Side effects vary by individual.
VAST-D II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quick Inventory of Depressive Symptoms (QUIDS-C16)
Side effects data
From 2018 Phase 3 trial • 226 Patients • NCT0303919235%
Dizziness
29%
Dissociation
20%
Nausea
19%
Headache
19%
Somnolence
17%
Blood Pressure Increased
14%
Dysgeusia
13%
Constipation
9%
Vision Blurred
7%
Vomiting
7%
Hypoaesthesia
6%
Insomnia
6%
Sedation
6%
Vertigo
5%
Dizziness Postural
5%
Anxiety
2%
Depression Suicidal
1%
Diabetic Ketoacidosis
1%
Depression
1%
Suicide Attempt
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Plus SOC Antidepressant Treatment
Esketamine 84 mg Plus SOC Antidepressant Treatment
VAST-D II Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EsketamineExperimental Treatment1 Intervention
Intranasal spray of esketamine. Administered twice weekly for first 4 weeks, reduced to once weekly until week 12, then dosage will be determined by response and treating prescriber.
Group II: AripiprazoleActive Control1 Intervention
Participants will be randomized in a 1:1 ratio of equal allocation to either adjunctive ARI (n=470) or adjunctive IN ESK (n=470), stratified by participating site.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esketamine
2015
Completed Phase 3
~2520
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,453 Total Patients Enrolled
Somaia Mohamed, PhDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 Previous Clinical Trials
1,522 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of a bladder condition called interstitial or ulcerative cystitis.You have been diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, or another type of mental illness that causes hallucinations or delusions.You have a current episode of major depressive disorder (MDE, single or recurrent, non-psychotic).You have a history of weakened blood vessels or abnormal connections between arteries and veins.You have a history of being addicted to ketamine.You have been taking an antidepressant for at least 6 weeks but it has not improved your condition.You have been diagnosed with a serious brain disorder that affects your memory and thinking abilities, or any other condition that affects the way your brain functions.You are currently taking any medication for mental health conditions.You have experienced 2 or more failed antidepressant trials in the last 2 years.You have been taking an antidepressant medication for at least 6 weeks, but it has not been effective in improving your condition.You have a history of bleeding in the brain.You are currently experiencing hallucinations or delusions during your depressive episode.You have been treated with ketamine or esketamine for depression in the past two years or during your current episode.You currently have severe depression based on a questionnaire called QIDS-C16 with a score higher than 14.You are at least 18 years old at the time of randomization.You are allergic to ESK or ketamine.Your depression score is currently higher than 14 on the QIDS-C16 scale.
Research Study Groups:
This trial has the following groups:- Group 1: Esketamine
- Group 2: Aripiprazole
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.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT05554627 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks accompany the use of Esketamine?
"As this treatment is approved, our team gives Esketamine a score of 3 on the 1 to 3 safety scale."
Answered by AI
In what locations is this research project taking place?
"Patients can join the trial at 27 different clinical sites, such as CERC (VISN1, West Haven, CT) in West Haven and William S. Middleton Memorial Veterans Hospital, Madison wi in Madison. Additionally there are 24 other locations available nationwide to participate."
Answered by AI
Who meets the criteria for participation in this clinical trial?
"Qualified participants of this research project must be suffering from psychosis, involutional and between 18-74 years old. The investigators are seeking around 940 volunteers for their investigation."
Answered by AI
Are there any unfilled slots for participants in this trial?
"According to clinicaltrials.gov, the trial first posted on March 1st 2023 is not currently seeking participants; however, there are 820 other studies actively recruiting patients at this time."
Answered by AI
Does this clinical trial accept elderly patients?
"This trial is open to individuals aged between 18 and 74. There are 105 studies for minors and 591 specifically targeting seniors."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
New Mexico
California
Other
How old are they?
18 - 65
What site did they apply to?
Phoenix VA Health Care System, Phoenix, AZ
Philadelphia MultiService Center, Philadelphia, PA
Michael E. DeBakey VA Medical Center, Houston, TX
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
3+
What questions have other patients asked about this trial?
How long does screening take? How long do screening visits take? What is the financial incentive for the study?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I've tried over 7 drugs to no avail. I have a new phone number 7209690448.
PatientReceived no prior treatments
I have tried several other drugs with no improvement. I ve tried 5 other drugs over 7 years to no avail, plus talk therapy.
PatientReceived no prior treatments
Taken many previous meds for depr. c only temp relief (i.e. one year's duration)over p 30 yrs.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- New Mexico VA Health Care System, Albuquerque, NM: < 24 hours
Average response time
- < 1 Day
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