Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-27 @ 9:06 AM
Study NCT ID:
NCT04701866
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2021-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music as an Intervention to Improve Hemodynamic Tolerability of Ketamine in Depression
Sponsor:
Douglas Mental Health University Institute
Organization:
Study Overview
Official Title:
Music as a Potential Intervention to Improve Hemodynamic Tolerability of Repetitive Sub-Anesthetic IV Ketamine Infusions in Bipolar and Unipolar Depression: A Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: