Clinical TrialSuicidalityKetamineKetamineUnknown status

A Single Ketamine Infusion Combined With Music for Suicidal Ideation

This open-label trial (n=200) investigates the efficacy of a single ketamine infusion combined with music for suicidal ideation (SI) during a depressive episode.

Target Enrollment
200 participants
Study Type
Phase II interventional
Design
Randomized

Detailed Description

Randomized, factorial, open-label trial (n=200) testing IV ketamine 0.5 mg/kg over 40 minutes and a 60-minute music playlist (Nils Frahm) independently and combined versus treatment as usual in patients presenting with a depressive episode and suicidal ideation.

Primary outcome is reduction in suicidal ideation (SSI) at 4 weeks (response = ≥50% reduction); secondary outcomes include MADRS, SSI over follow-up, adverse events and safety monitoring. Participants monitored in ER/hospital with vitals every 15 minutes during and after infusion; weekly phone follow-up for 4 weeks.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Ketamine

experimental

IV ketamine 0.5 mg/kg infused over 40 minutes

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Infused over 40 minutes

Ketamine + Music

experimental

IV ketamine 0.5 mg/kg infused over 40 minutes with 60 minutes of music

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Infused over 40 minutes

  • Compound
    via Other• single dose

    60 minutes playlist by Nils Frahm played during and around infusion

Music

experimental

60 minutes of pre-planned music without ketamine

Interventions

  • Compound
    via Other• single dose

    60 minutes playlist by Nils Frahm

Treatment as usual

waitlist

Treatment as usual without ketamine or music

Interventions

  • Compound
    via Other

    Treatment as usual (possible hospitalisation, medication, psychotherapy, outpatient referrals, suicide safety planning)

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Adults age 18-64
  • DSM-IV diagnosis of a depressive episode as determined by the Mini International Neuropsychiatric Interview (MINI)
  • Montgomery–Åsberg Depression Rating Scale (MADRS) ≥ 28
  • Suicidal ideation at baseline defined as Scale for Suicidal Ideation (SSI) score ≥ 4
  • Diagnosis may include major depressive disorder, bipolar disorder, or substance-induced mood disorder
  • Informed consent obtained

Exclusion Criteria

  • Exclusion Criteria:
  • Active psychotic symptoms
  • Current manic episode
  • Previous diagnosis of schizophrenia or schizoaffective disorder
  • Diagnosis of intellectual disability or autism spectrum disorder
  • Major neurocognitive disorder
  • History of ketamine abuse or dependence
  • Hypersensitivity to esketamine, ketamine, or any excipients
  • Uncontrolled clinically significant medical conditions (e.g., respiratory illness requiring oxygen, previously documented prolonged QTc, aneurysmal vascular disease, arteriovenous malformation, intracerebral hemorrhage, unstable cardiac disease including prior myocardial infarction)
  • Positive urine pregnancy test
  • Previous treatment of depression with ketamine or esketamine

Study Details

  • Status
    Unknown status
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment200 participants
  • Timeline
    Start: 2021-07-01
    End: 2023-04-30
  • Compounds
    KetamineKetamine
  • Topic
    Suicidality

Locations

UT Health East Texas — Tyler, Texas, United States

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