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.
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. In August 2022, the targeted enrollment was expanded to include outpatient participants, the anticipated enrollment was increased from 60 to 100 participants as a result.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
92
CBT: In-person and computer-based components (Good Days Ahead) First 4 weeks of CBT are twice weekly; thereafter weekly CBT
UAB Medicine | Heersink School of Medicine
Birmingham, Alabama, United States
Yale University
New Haven, Connecticut, United States
Emory University
Atlanta, Georgia, United States
To determine the feasibility of performing a larger study with similar design by measuring of recruitment rates.
Feasibility will be evaluated by measures of recruitment rates measured by attaining 80% of recruitment target will be considered feasible.
Time frame: Recruitment rates will be assessed at 18 months.
To determine the feasibility of performing a larger study with similar design by measuring attrition.
Feasibility will be evaluated by measures of attrition rates by attaining 80% of retention will of 70% of participants will be considered feasible.
Time frame: Attrition will be assessed at 18 months.
Reasons for discontinuation
Feasibility will be evaluated by measures of reasons for discontinuation regardless of clinical state, to Week 18 or later will be considered feasible.
Time frame: Discontinuation will be assessed at 18 months.
To determine the safety of performing a larger study with similar design.
Safety will be evaluated by measures of the number by type of protocol deviations.
Time frame: Safety will be assessed at 18 months.
Evaluate the appropriateness of the proposed tests of cognitive control measures in exploring the mechanisms of change.
Appropriateness will be evaluated by the proportion of patients who are able to complete the cognitive control assessments. As this is a feasibility study, we do not have pre-specified quantitative cutoffs.
Time frame: The appropriateness will be assessed at the end of study (18 months).
Efficacy of esketamine/CBT combination compared to esketamine/TAU in reducing the risk of suicide.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Efficacy will be measured by the response to the MADRS (Montgomery-Asberg Depression Rating Scale). The MADRS is a 10 question assessments conducted in an interview setting.
Time frame: Measured at Baseline, study day 2, study day 15, study day 30, weeks 7 - 17, week 18, week 26. The primary observation will be the last observation carried forward per protocol at Week 18.