Phase 3
N=32
Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial
Postoperative Depression
Bottom Line
View on ClinicalTrials.gov: NCT05233566 ↗Enrolled (actual)
32
Serious AEs
21.9%
Results posted
Apr 2024
Primary outcome: Primary: Fraction of Approached Patients Who Enroll and Are Randomized — 1; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketamine (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fraction of Approached Patients Who Enroll and Are Randomized |
1; 31 | — |
| PRIMARY Fraction of Randomized Patients Who Complete the Study Infusion |
15; 15 | — |
| PRIMARY Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points |
13; 6 | — |
| SECONDARY Depressive Symptoms on Day 4 |
4; 6 | — |
| SECONDARY Delta Sleep Ratio on Night 1 Following Study Medication |
3.01; 0.96 | — |
Summary
This protocol describes a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial testing the hypothesis that a postoperative sustained, low-dose ketamine infusion can prevent postoperative depressive symptoms when administered to a targeted population of neurosurgical patients with a history of depression.
Eligibility Criteria
Inclusion Criteria
- Able to provide written, informed consent
- Aged 18 or older
- Scheduled for non-ambulatory surgery scheduled to last at least 2 hours at Barnes-Jewish Hospital
- Past medical history of depression, defined as one or more of the following criteria
- Previous diagnosis by a psychiatrist or primary care physician in an outpatient or inpatient setting, by patient report or chart documentation
- Prescription of an oral antidepressant by a psychiatrist or primary care physician for a mood disorder
Exclusion Criteria
- Bipolar depression
- Concurrent use of a medication contraindicated with ketamine
- Emergent surgery
- Known or suspected elevation in intracranial pressure
- Current subarachnoid hemorrhage
- Carotid endarterectomy or arteriovenous malformation repair
- Allergy to ketamine
- Any condition in which a significant elevation of blood pressure would constitute a serious hazard (e.g., aortic dissection, pheochromocytoma)
- Known history of dementia
- Pregnancy or lactation
- Inability to converse in English
- Concurrent enrollment in another interventional trial
Data sourced from ClinicalTrials.gov (NCT05233566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.