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Ketamine + Mindfulness for Depression

NCT05168735 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-08-20

Study results available
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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.

Conditions

  • Depression, Unipolar

Interventions

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

Sponsors & Collaborators

  • Rebecca Price

    lead OTHER

Principal Investigators

  • Rebecca Price, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-08-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05168735 on ClinicalTrials.gov