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

NCT05233566 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 202201107
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Depression

Outcome Measures

Primary Outcomes (3)

• Fraction of Approached Patients Who Enroll and Are Randomized

  The numerator will include all patients who are randomized to receive either ketamine or placebo. The denominator will include all patients who are approached by the research team to evaluated eligibility and offer consent.

  3 days after surgery

• Fraction of Randomized Patients Who Complete the Study Infusion

  The numerator will include all participants who received the entire study medication infusion as planned. The denominator will include all participants who are randomized to receive either ketamine or the placebo.

  3 days after surgery

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

  Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS) at pre-operative baseline and on post-infusion days 1, 2, 4, 7, and 14. MADRS scores range 0 to 60, with higher scores representing worse depression. The numerator will include all patients with MADRS scores documented at all 6 time points. The denominator will include all participants who are randomized to receive either ketamine or the placebo.

  14 days after the intervention

Secondary Outcomes (2)

• Depressive Symptoms on Day 4

  4 days after the intervention

• Delta Sleep Ratio on Night 1 Following Study Medication

  2 days after intervention

Study Arms (2)

Ketamine Arm

EXPERIMENTAL

Following surgery and extubation, patients will receive ketamine 0.5 mg/kg over 10 minutes followed by an infusion of 0.3 mg/kg/h for 2 hours 50 minutes.

Drug: Ketamine

Control Arm

PLACEBO COMPARATOR

Following surgery and extubation, patients will receive normal saline at an equal rate to that used in the ketamine arm.

Drug: Normal saline

Interventions

Normal saline DRUG

IV fluid acting as a placebo

Control Arm

Ketamine DRUG

NMDA antagonist

Also known as: Ketalar

Ketamine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Fritz BA, Tellor Pennington BR, Dalton C, Horan C, Palanca BJA, Schweiger JA, Griffin L, Tumwesige W, Willie JT, Farber NB. Ketamine for postoperative avoidance of depressive symptoms: the K-PASS feasibility randomised trial. BJA Open. 2023 Dec 15;9:100245. doi: 10.1016/j.bjao.2023.100245. eCollection 2024 Mar.

  PMID: 38179107 DERIVED

• Fritz BA, Tellor Pennington BR, Palanca BJA, Schweiger JA, Willie JT, Farber NB. Protocol for the Ketamine for Postoperative Avoidance of Depressive Symptoms (K-PASS) feasibility study: A randomized clinical trial. F1000Res. 2022 May 11;11:510. doi: 10.12688/f1000research.121529.1. eCollection 2022.

  PMID: 37483552 DERIVED

MeSH Terms

Interventions

Ketamine; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Bradley Fritz
• Organization: Washington University School of Medicine

bafritz@wustl.edu

3142733453

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 10, 2022
• Study Start: April 25, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: February 12, 2026
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Locations

US (1)