Clinical TrialTreatment-Resistant Depression (TRD)KetamineKetamineCompleted

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

Randomised, single-blind (assessors) parallel trial (actual n=32) comparing curated music versus no music during six 40-minute IV ketamine infusions (0.5 mg/kg) in treatment-resistant depression; primary outcome is systolic blood pressure change during infusions.

Target Enrollment
32 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Randomised, assessor-blinded, single-centre study comparing curated music to no-music usual care during a course of six low-dose IV ketamine infusions (0.5 mg/kg) over four weeks in participants with treatment-resistant unipolar or bipolar depression.

The primary outcome is change in systolic blood pressure from infusion start to 40 minutes (end of infusion). Secondary outcomes include repeated measures of mood, anxiety, suicidality, psychological and physical pain, and aspects of the treatment experience.

Music is delivered via headphones selected with participant input; infusion tolerability and haemodynamic responses are compared between groups with matched clinician contact time.

Study Protocol

Preparation

sessions

Dosing

6 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Music

experimental

Curated music via headphones during each ketamine infusion (6 infusions over 4 weeks).

Interventions

  • Ketamine0.5 mg/kg
    via IV• six infusions• 6 doses total

    0.5 mg/kg IV infusion over 40 minutes per session.

  • Compound
    via Other• six sessions

    Curated music via headphones starting at infusion commencement and ending ~55 minutes later; selection discussed pre-infusion.

Usual care

active comparator

No music during ketamine infusions; contact time matched.

Interventions

  • Ketamine0.5 mg/kg
    via IV• six infusions• 6 doses total

    0.5 mg/kg IV infusion over 40 minutes per session; music not permitted.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion Criteria

  • Bipolar and unipolar current depressive episode (DSM-5) despite at least two adequate trials of Level-1 evidence psychiatric medications.
  • No active substance use disorder (beyond nicotine use disorder).
  • No contraindication to ketamine.
  • Not of childbearing potential, defined as postmenopausal (no menses for 12 months) or permanently sterile; FSH may be used to confirm postmenopausal status if needed.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and agree to use a highly effective method of contraception during treatment and after the last infusion.
  • Female subjects of childbearing potential must use a highly effective method of contraception beginning at least two weeks before and continued during ketamine infusions.
  • Male subjects sexually active with a woman of childbearing potential must agree to use a double-barrier contraception method; if sexually active with a pregnant woman must use a condom; males must not donate sperm during treatment and for ~90 days after last dose.
  • Abstain from grapefruit juice on the day of infusions.
  • Provision of written informed consent.

Exclusion Criteria

  • Baseline blood pressure outside normal limits, i.e. above 140/90 mmHg when measured thrice in a quiet room.
  • Significant hearing impairment not improved with aids or unwillingness to listen to music during treatment.
  • Prior non-response to esketamine or ketamine in the current episode.
  • Known intellectual disability or autism spectrum disorder.
  • Unable to attend regular visits to the Depressive Disorders Program at Douglas Mental Health University Institute.
  • Depression secondary to stroke, cancer, or other severe medical illnesses.
  • Known risk factors for intracranial haemorrhage (prior significant trauma, known aneurysm, prior neurosurgery).
  • Clinically relevant disease (renal/hepatic impairment, significant coronary disease, recent MI within 1 year, cerebrovascular disease, viral hepatitis B/C, AIDS).
  • Prior or current substance abuse/dependence (except caffeine or nicotine) or recent (past 12 months) alcohol or cannabis use disorder.
  • Positive toxicology screen for non-prescribed drugs.
  • Unwilling/unable to hold benzodiazepines from evening prior to infusion.
  • Unwilling/unable to discontinue narcotics 5 half-lives before infusion.
  • Unwilling/unable to discontinue memantine 5 half-lives before infusions.
  • Pregnant, lactating, or of childbearing potential and unwilling to use approved contraception.
  • Unstable clinical finding that would be negatively affected by or affect medication (e.g., unstable diabetes, unstable angina).
  • AST/ALT >3x upper normal limit at screening.
  • Uncorrected thyroid disease requiring unstable dosing.
  • Clinically significant laboratory deviations as judged by clinician.
  • Abnormal ECG as determined clinically.
  • History of seizure disorder (except febrile convulsions).
  • Known intolerance or hypersensitivity to ketamine.
  • Acute psychotic symptoms.
  • Any significant recent acute decline in exercise tolerance.

Study Details

Locations

Jewish General Hospital — Montreal, Quebec, Canada
Douglas Mental Health University Institute — Montreal, Quebec, Canada

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