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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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

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