Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention (ENDURE)
Depression and Suicide
About this trial
This is an interventional treatment trial for Depression and Suicide focused on measuring Depression, Suicide
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- UAB Medicine | Heersink School of MedicineRecruiting
- Yale UniversityRecruiting
- Emory UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
CBT Cognitive Behavioral Therapy
TAU Treatment As Usual
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.
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).