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Cognitive Behavioral Therapy After Esketamine for Depression with Suicidal Ideation (ENDURE Trial)
N/A
Recruiting
Led By Samuel T Wilkinson, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of major depressive disorder as confirmed by the MINI (inpatient) or the HAM-D-17 (outpatient)
Males or females ages 18 through 65 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the appropriateness will be assessed at the end of study (18 months).
Awards & highlights
ENDURE Trial Summary
This trial is testing if adding computer-assisted CBT to esketamine treatment for Major Depression with Suicidal Ideation is more effective than just esketamine treatment alone.
Who is the study for?
Adults aged 18-65 with major depression and suicidal thoughts, who are recommended for esketamine treatment, can join. They must be willing to use contraception and follow the trial procedures. Excluded are those pregnant or breastfeeding, with certain cognitive disorders, no response to prior ketamine treatments, substance abuse issues within the last 6 months, or other serious medical/psychiatric conditions.Check my eligibility
What is being tested?
The study tests if Cognitive Behavioral Therapy (CBT) after esketamine treatment helps prevent relapse in major depression with suicidal ideation. Participants will either receive computer-assisted CBT or Treatment As Usual (TAU) randomly after their initial esketamine therapy.See study design
What are the potential side effects?
Esketamine may cause dissociation, dizziness, nausea, sedation, increased blood pressure and anxiety. The side effects of CBT are minimal but can include temporary increases in distress due to focusing on difficult experiences during therapy.
ENDURE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with major depression.
Select...
I am between 18 and 65 years old.
ENDURE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the appropriateness will be assessed at the end of study (18 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the appropriateness will be assessed at the end of study (18 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the appropriateness of the proposed tests of cognitive control measures in exploring the mechanisms of change.
Reasons for discontinuation
To determine the feasibility of performing a larger study with similar design by measuring attrition.
+2 moreSecondary outcome measures
Efficacy of esketamine/CBT combination compared to esketamine/TAU in reducing the risk of suicide.
Other outcome measures
To evaluate CTAS (Computer-Assisted Cognitive-Behavior Therapy for Depression).
Feeling suicidal (finding)
To evaluate the RRS (Ruminative Responses Scale).
+4 moreENDURE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TAU Treatment As UsualExperimental Treatment1 Intervention
Participants will undergo Treatment as usual (TAU). These patients will undergo standard, post-hospitalization clinical treatments, which many include physician visits and psychotherapy (except for formal CBT).
Group II: CBT Cognitive Behavioral TherapyActive Control1 Intervention
Participants will receive CBT, which will consist of in-person and computer-based component (based on Good Days Ahead). This will consist of 20 sessions given over 16 weeks.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,341 Total Patients Enrolled
63 Trials studying Depression
20,546 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,667 Total Patients Enrolled
666 Trials studying Depression
251,484 Patients Enrolled for Depression
Samuel T Wilkinson, MDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried Esketamine or ketamine before, and it didn't work for me.I am unable to understand and agree to the study's details on my own.You have been actively using drugs (except for tobacco) within the past 6 months.You have a condition that affects your thinking or understanding, making it difficult for you to participate in cognitive-behavioral therapy (CBT).You have any other existing medical or mental health condition that the researcher believes could make it risky for you to participate in the study or could make it difficult for you to take part.I've had 6 or more Esketamine treatments of 56 mg or higher without improvement.I've had 6 IV ketamine treatments without feeling better.I am in or will join a structured therapy program with homework and session agendas.I cannot take Esketamine due to certain health conditions or allergies.I have been diagnosed with major depression.I have been diagnosed with a specific mental health condition like bipolar disorder or schizophrenia.I have not taken Esketamine or ketamine in the last 3 months.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: CBT Cognitive Behavioral Therapy
- Group 2: TAU Treatment As Usual
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: NCT04760652 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is geriatric participation being solicited for this experiment?
"Eligibility criteria for this medical experiment mandate that participants must be older than 18 and younger than 65."
Answered by AI
Are researchers still accepting participants for this research project?
"Affirmative. The clinicaltrials.gov webpage reveals that this venture, which was initially unveiled on March 5th 2021 is presently seeking applicants. Approximately 100 individuals are needed between two distinct trial sites."
Answered by AI
Who meets the criteria to participate in this research experiment?
"This medical research is seeking 100 individuals suffering from depression with ages ranging between 18 and 65. Prospective participants must be able to commit to attending all scheduled appointments, adhere to a reliable contraceptive method if they are sexually active, and meet the other requirements set out by investigators in order to participate."
Answered by AI
How many participants are enrolled in this clinical experiment?
"Affirmative. Reported on clinicaltrials.gov, the trial that was initiated on March 5th 2021 is now actively recruiting potential candidates. Approximately 100 individuals need to be registered from 2 medical centres."
Answered by AI
Who else is applying?
What state do they live in?
Rhode Island
Georgia
Connecticut
How old are they?
18 - 65
What site did they apply to?
Emory University
Yale University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
1
Why did patients apply to this trial?
Depression for most of my adult life. I am very interested in a ketamine trial.
PatientReceived 2+ prior treatments
I've tried many things. They dont seem to work. I'm hoping you can shed light on that.
PatientReceived no prior treatments
To Help with my depression. I have had presistent depression for most of my life and have taken many many medication with no real effect.
From what I have read, this trial may be very helpful to help with my recovery.
Thank you.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do visits take? How long do the visits take? FROM WHAT I UNDERSTAND THIS IS A NASAL ADMINISTERED KATIMINE
AM I CORRECT? ALSO WHAT IS THE TIME FRAME?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Emory University: < 48 hours
Average response time
- < 2 Days
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