Cognitive Behavioral Therapy Following Esketamine... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

Inclusion Criteria:
Participants are eligible for the study if they meet all the following criteria:
1. Written informed consent before any study procedures are performed
2. Meeting criteria for inpatient admission for suicidal ideation or attempt at one of the study sites
3. Recommended by a physician for esketamine treatment
4. Males or females ages 18 through 65 years of age
5. Diagnosis of major depressive disorder as confirmed by the MINI (inpatient) or the HAM-D-17 (outpatient)
6. 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)
7. 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

Exclusion Criteria:
Participants are excluded if they meet any of the following criteria:
1. Active substance use disorder (except tobacco) within 6 months of screening date
2. Meets DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or pervasive development disorder
3. Dementia or other cognitive disorder or intellectual disability that would impair the subject's ability to meaningfully engage in CBT (per investigator judgment)
4. 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
5. 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
6. Previous Esketamine or ketamine treatment that did not produce a clinical response as outlined: 6 treatments with Esketamine at a dose of 56 mg or more with no clinical response; or 6 treatments of IV ketamine at a dose between 0.4 mg/kg and 0.7 mg/kg with no clinical response; patients must not have received Esketamine or ketamine treatment within the past 12 weeks of time of enrollment
7. The patient is pregnant or breastfeeding
8. Unable to give informed consent
9. Was previously enrolled/randomized into the trial
10. 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

Company

Product

Legal

Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention (ENDURE)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Esketamine + CBT

Interventions

Esketamine + TAU

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators