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

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 measures changes 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.

Topic Music Bipolar Disorder Treatment-Resistant Depression Depression Pain
Compound Ketamine Placebo
Country Canada
Visit trial
Status Completed
Results Published No
Start date 11 January 2021
End date 01 October 2022
Phase Not Applicable
Design Blinded
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 75
Therapy No

Trial Details

Depression is the first cause of disability worldwide, and approximately 1 in 3 patients will fail to respond to current treatments. Intravenous (IV) low-dose ketamine has remarkable efficacy in even the most treatment-resistant depression (here defined as failure to at least two adequate trials of Level 1-evidence psychiatric medications), inducing remission in 25-50%. Over 100 randomized clinical trials (RCTs) show that music can mitigate hemodynamic and psychological stress caused by even highly invasive medical procedures. Though never studied, music may similarly improve ketamine tolerability. In this randomized, single-blind (assessors will not know whether participants receive music or not) single-center trial, 20 participants with TRD will receive 1) curated music or 2) no music during their course of 6 IV ketamine treatments (0.50mg/kg bodyweight) over 4 weeks. The primary aim is to compare changes in systolic blood pressure from the beginning to the end (40 minutes, peak plasma concentration) of each infusion between groups.

Trial Number NCT04701866

Sponsors & Collaborators

Douglas Mental Health University Institute
This company doesn't have a full profile yet, it is linked to a clinical trial.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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