CompletedPhase 3

Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial

United States32 participantsStarted 2022-04-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Fraction of Approached Patients Who Enroll and Are Randomized

Timeframe: 3 days after surgery

Fraction of Randomized Patients Who Complete the Study Infusion

Timeframe: 3 days after surgery

Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points

Timeframe: 14 days after the intervention

Trial details

NCT IDNCT05233566

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-08

Results submitted2024-02-15

View on ClinicalTrials.gov More Postoperative Depression trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Fraction of Approached Patients Who Enroll and Are Randomized

Timeframe: 3 days after surgery

Fraction of Randomized Patients Who Complete the Study Infusion

Timeframe: 3 days after surgery

Fraction of Randomized Patients With Depression Rating Scale Scores at All Specified Time Points

Timeframe: 14 days after the intervention