CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Musicother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04701866
NCT04701866N/ACompleted
CompareCT.gov

Music as a Potential Intervention to Improve Hemodynamic Tolerability of Repetitive Sub-Anesthetic IV Ketamine Infusions in Bipolar and Unipolar Depression: A Pilot Study

Douglas Mental Health University Institute·interventional·Posted Jan 8, 2021·Updated Oct 4, 2022

In Brief

A clinical study evaluating Music for Depressive Disorder, Treatment-Resistant and 3 related conditions. Completed, enrolled 32 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Unipolar Depression, Depression, Bipolar
CountriesCanada
CollaboratorsRéseau québécois sur le suicide, les troubles de l'humeur et les troubles associés

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 8, 2021
Enrollment StartJan 11, 2021
Primary CompletionAug 24, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.5 years ago

Interventions

Musicother

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.).