NCT05168735

Ketamine + Mindfulness for Depression

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Rebecca Price · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this project, the investigators will administer a single infusion of IV ketamine to depressed patients and randomize the patients to receive either a) usual/typical infusion conditions or b) mindfulness training and exercises in conjunction with the infusion. Investigators will test whether the conjunction of ketamine + mindfulness enhances the reductions in depression following a single ketamine infusion.

Detailed description

NOTE: The study's target sample size was revised after beginning the study, based on a revised available budget.

Conditions

• Depression, Unipolar

Interventions

Type	Name	Description
DRUG	Intravenous Ketamine	Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
BEHAVIORAL	Brief Mindfulness Exercises	30min guided training in mindfulness meditation immediately prior to infusion
BEHAVIORAL	Academic Exercises	30min of mental math and other academic cognitive puzzles completed silently/mentally

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-08-01
• Completion: 2023-09-01
• First posted: 2021-12-23
• Last updated: 2024-08-20
• Results posted: 2024-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study