New Haven,
Connecticut
06511
Purpose:
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 CBT (computer-assisted) or TAU alone following esketamine.
Study summary:
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 treatment in patients hospitalized for suicidal ideation or
suicide attempt.
Specific Aim 2: To evaluate the appropriateness and utility of the proposed tests of
cognitive control measures in exploring the mechanisms underlying the effects on depression
of esketamine and the combination of esketamine+CBT.
Specific Aim 3: To examine the efficacy of esketamine+CBT combination compared to
esketamine+TAU in reducing suicidal ideation.
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
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:
- 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 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.
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