MedTrace Logo

Music as an Intervention to Improve Hemodynamic Tolerability of Ketamine in Depression

NCT04701866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-10-04

No results posted yet for this study

Summary

The purpose of this study is to assess the impact of music on patients receiving a course of intravenous (IV) ketamine for treatment-resistant depression (TRD), both unipolar and bipolar. The primary outcome is changes in in systolic blood pressure throughout each 40-minute infusion. Secondary outcomes include repeated measures of mood, anxiety, suicidality, and psychological/physical pain. Aspects of the treatment experience, with and without music, will also be explored.

Conditions

  • Depressive Disorder, Treatment-Resistant
  • Depressive Disorder, Major
  • Unipolar Depression
  • Depression, Bipolar

Interventions

OTHER

Music

Music will be provided via headphones during all 6 ketamine treatments, beginning at the commencement of each infusion and ending 55 minutes later. On the day of each infusion, before the treatment begins, clinicians will discuss music choices with participants in order to select amongst one of several options that have been designed for this purpose (length, genre, intensity, etc.).

Sponsors & Collaborators

  • Réseau québécois sur le suicide, les troubles de l'humeur et les troubles associés

    collaborator UNKNOWN

  • Douglas Mental Health University Institute

    lead OTHER

Principal Investigators

  • Stéphane Richard-Devantoy, MD, PhD · Douglas Mental Health University Insitute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-08-24
Completion
2022-08-24

Countries

  • Canada

Study Locations

More Related Trials

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 NCT04701866 on ClinicalTrials.gov