Ketamine + Cognitive Training for Suicidality in the Medical Setting
Randomized, triple-blind Phase IV trial (n=200) testing a single IV ketamine 0.5 mg/kg infusion plus computer-based cognitive training versus sham training and treatment-as-usual in medically hospitalized suicidal patients.
Detailed Description
This study evaluates the acute and longer-term impact of a single subanesthetic IV ketamine infusion (0.5 mg/kg) in suicidal medical inpatients and tests whether computer-based cognitive training (8 sessions) can extend ketamine's rapid effects.
Design: randomized, parallel-group, triple-masked, four-arm trial comparing ketamine with sham training, ketamine with active training, and TAU variants; primary aims focus on suicidality outcomes and trajectories over predefined time windows per registry clarifications.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Ketamine + Cognitive Training
experimentalSingle IV ketamine 0.5 mg/kg plus 8-session computer-based cognitive training.
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
- Compoundvia Other• 8 sessions
Computer-based cognitive training (8 sessions)
Ketamine + Sham Training
activeSingle IV ketamine 0.5 mg/kg plus 8-session sham training.
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
- Compoundvia Other• 8 sessions
Sham training (8 sessions)
No-infusion (TAU) + Cognitive Training
active comparatorNo infusion (treatment as usual) with 8-session computer-based cognitive training.
Interventions
- Compoundvia Other• 8 sessions
Computer-based cognitive training (8 sessions)
- Compoundvia Other
No infusion (treatment as usual)
No-infusion (TAU) + Sham Training
activeNo infusion (treatment as usual) with 8-session sham training.
Interventions
- Compoundvia Other• 8 sessions
Sham training (8 sessions)
- Compoundvia Other
No infusion (treatment as usual)
Participants
Inclusion Criteria
- Participants who receive ketamine will:
- 1. be between the ages of 18 and 70 years
- 2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require follow-up psychiatric care (inpatient or outpatient)
- 3. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
- 4. be deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization
Exclusion Criteria
- 1. Presence of current/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
- 2. Mini-Mental State Exam (MMSE) < 21
- 3. Current pregnancy or breastfeeding
- 4. Reading level <5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
- 5. Past intolerance or hypersensitivity to ketamine or esketamine
- 6. Patients taking St John's Wort
- 7. Patients who have received ECT in the past 1 month prior to intake
- 8. Patients at ongoing risk for severe substance or alcohol withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
- 9. Arrested or incarcerated individuals brought in by the legal system for medical stabilization
Primary Results(1 publication)
Participants
Response Rates
≥50% decrease in the total depression (MADRS) score
full remission of all passive or active SI (worst SI score = 0)
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Ketamine + Cognitive Trainingexperimental | 16 | 16(100.0%) | — | — | 1(6.3%) |
| Ketamine + Sham Trainingactive | — | — | — | — | — |
| No-infusion (TAU) + Cognitive Trainingactive_comparator | — | — | — | — | — |
| No-infusion (TAU) + Sham Trainingactive | — | — | — | — | — |
* The paper reports that one patient experienced moderate anxiety, distress and nausea and requested to discontinue. Table 2 lists specific symptoms reported by the 16 patients. Since all 16 patients are accounted for in the symptom frequency percentages (e.g., 31.25% = 5/16), it is inferred that all participants experienced at least one TEAE.
* The study was an open-label design where the ketamine group was later pooled with the cognitive training groups for analysis; specific safety data for the sham training arm alone is not provided separately from the pooled ketamine sample.
* No specific safety data reported for this arm.
Study Details
- StatusActive not recruiting
- PhasePhase IV
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment200 participants
- TimelineStart: 2021-03-15End: 2026-03-02
- Compounds
- Topic