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NCT04701866
Music as an Intervention to Improve Hemodynamic Tolerability of Ketamine in Depression
NA trial testing Music in Depressive Disorder, Treatment-Resistant in 32 participants. Completed in 24 August 2022.
24 August 2022
Quick facts
| Lead sponsor | Douglas Mental Health University Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 11 January 2021 |
| Primary completion | 24 August 2022 |
| Estimated completion | 24 August 2022 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Music
Conditions studied
- Depressive Disorder, Treatment-Resistant — all drugs for Depressive Disorder, Treatment-Resistant →
- Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
- Unipolar Depression — all drugs for Unipolar Depression →
- Depression, Bipolar — all drugs for Depression, Bipolar →
Sponsor
Douglas Mental Health University Institute
Who can join
Adults 18 to 75, any sex, with Depressive Disorder, Treatment-Resistant or Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Imprinting: expanding the extra-pharmacological model of psychedelic drug action to incorporate delayed influences of sets and settings.
Garel N, Thibault Lévesque J, Sandra DA, Lessard-Wajcer J, et al · · 2023 · cited 6× · PMID 37533588 · DOI 10.3389/fnhum.2023.1200393 -
Music as an Intervention to Improve the Hemodynamic Response of Ketamine in Depression: A Randomized Clinical Trial.
Greenway KT, Garel N, Dinh-Williams LL, Beaulieu S, et al · · 2024 · cited 4× · PMID 38315489 · DOI 10.1001/jamanetworkopen.2023.54719 -
The Music for Subanesthetic Infusions of Ketamine randomised clinical trial: ketamine as a psychedelic treatment for highly refractory depression.
Greenway KT, Garel N, Dinh-Williams LL, Thibault Lévesque J, et al · · 2026 · cited 3× · PMID 40528492 · DOI 10.1192/bjp.2025.102
Verify or expand the search:
- PubMed search for NCT04701866
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Music
Trials testing the same drug.
- NCT07206186 — Effect of Music on Patient Comfort · NA · recruiting
- NCT06536296 — The Impact of Music Medicine on Preterm Brain Development and Behavior · NA · recruiting
- NCT06621238 — The Effect of Musıc on Labor Paın, Anxıety and Breastfeedıng Success · NA · recruiting
- NCT06539754 — Patient Satisfaction During Cesarean Delivery · NA · completed
- NCT06957990 — Evaluation of Music Therapy for Pre-op/Intra-op During Hernia Surgery to Decrease the Need for Narcotics · NA · enrolling by invitation
Other recruiting trials for Depressive Disorder, Treatment-Resistant
Currently open trials in the same condition.
- NCT07053345 — A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression · Phase 4 · recruiting
- NCT06668571 — Intravenous Ketamine for Treatment-Resistant Depression · Phase 2 · recruiting
- NCT06511908 — Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resi · Phase 2 · recruiting
- NCT05570344 — rTMS With and Without Text4Support for the Treatment of Resistant Depression. · NA · recruiting
- NCT05641623 — OSU6162 as add-on in SSRI/SNRI-resistant Depression · Phase 2 · recruiting
Other Douglas Mental Health University Institute trials
Trials by the same sponsor.
- NCT07002996 — Spatial Memory Training and Cognitive Function · NA · recruiting
- NCT06978465 — DIALOG: Understanding Disorganisation: A Language-focused Global Initiative in Psychosis · not yet recruiting
- NCT06978452 — Behavioural Development, Long-term Outcomes and Opportunities to Optimize Youth Mental Health Trajectories · recruiting
- NCT06978894 — Predicting Psychotic Relapse Using Speech-Based Early Detection · recruiting
- NCT06893393 — Virtual Travel Into Nature for Individuals With Lived Experience of Severe Mental Disorders · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04701866 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Douglas Mental Health University Institute
- Last refreshed: 4 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04701866.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing