Status:
COMPLETED
Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression and Suicide
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a rater-blinded, randomized controlled trial. All patients will receive esketamine for treatment of Major Depression with Suicidal Ideation (MDSI). Subjects will be randomized (1:1) to receive...
Detailed Description
Specific Aim 1: To determine the feasibility and safety of performing a larger study examining the effectiveness and mechanism of action of CBT to improve the longer-term outcomes following esketamine...
Eligibility Criteria
Inclusion
- Participants are eligible for the study if they meet all the following criteria:
- Written informed consent before any study procedures are performed
- Meeting criteria for inpatient admission for suicidal ideation or attempt at one of the study sites
- Recommended by a physician for esketamine treatment
- Males or females ages 18 through 65 years of age
- Diagnosis of major depressive disorder as confirmed by the MINI (inpatient) or the HAM-D-17 (outpatient)
- Willing to adhere to a reliable form of contraception throughout the trial and for one month following completion of the trial (for subjects who are sexually active)
- In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study
Exclusion
- Participants are excluded if they meet any of the following criteria:
- Active substance use disorder (except tobacco) within 6 months of screening date
- Meets DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or pervasive development disorder
- Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to meaningfully engage in CBT (per investigator judgment)
- Any other medical or psychiatric comorbidity that the investigator judges would put the participant at additional undue risk due to study participation or would impair subject's ability to participate in the study.
- Current or planned participation in a formal CBT program defined by the following characteristics, each session has an agenda, a homework assignment is given at each session, and the homework assignment from the previous session is reviewed at the following appointment.
- Previous Esketamine or ketamine treatment that did not produce a clinical response as outlined below.
- 6 treatments with Esketamine at a dose of 56 mg or more with no clinical response
- 6 treatments of IV ketamine at a dose between 0.4 mg/kg and 0.7mg /kg with no clinical response Patients must not have received Esketamine or ketamine treatment within the past 12 weeks of time of enrollment.
- The patient is pregnant or breastfeeding
- Unable to give informed consent
- Was previously enrolled/randomized into the trial
- Patients who have a contraindication to receiving Esketamine including any of the following:
- aneurysmal vascular disease
- arteriovenous malformation
- history of intracerebral hemorrhage
- hypersensitivity to esketamine or ketamine
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04760652
Start Date
March 5 2021
End Date
June 30 2025
Last Update
July 14 2025
Active Locations (3)
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1
UAB Medicine | Heersink School of Medicine
Birmingham, Alabama, United States, 35294
2
Yale University
New Haven, Connecticut, United States, 06511
3
Emory University
Atlanta, Georgia, United States, 30329