Clinical TrialDepressive DisordersKetamineCompleted

Ketamine for Depression and Suicide Risk

Single-group, open-label Phase II study (n=12) of IV ketamine infusions (0.3 mg/kg/hr over 100 minutes) given thrice-weekly for up to 2 weeks with weekly continuation x4 for remitters, in hospitalised adults with treatment-resistant depression and elevated suicide risk.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This single-arm, open-label trial evaluated intravenous ketamine delivered as an infusion at 0.3 mg/kg/hr over 100 minutes (approximately 0.5 mg/kg per infusion) in hospitalised adults with major depressive disorder or bipolar depression and elevated suicide risk. Acute treatment consisted of thrice-weekly infusions for up to two weeks; participants achieving remission at any acute visit entered a continuation phase of once-weekly infusions for four weeks and then had post-continuation follow-up visits.

Primary efficacy assessments used the Montgomery–Åsberg Depression Rating Scale (MADRS) with remission defined as MADRS total ≤9 24 hours after an infusion; suicidal ideation was monitored clinically and via the MADRS suicide item. Safety assessments included adverse events and standard clinical monitoring during and after infusions.

Study Protocol

Preparation

0 sessions

Dosing

6 sessions
100 min each

Integration

0 sessions

Study Arms & Interventions

Ketamine infusion

experimental

Single-group, two-phase intravenous ketamine treatment: acute-phase thrice-weekly infusions up to 2 weeks; remitters received once-weekly continuation x4.

Interventions

  • Ketamine0.3 mg/kg/hr
    via IV• thrice-weekly (up to 6), then weekly for remitters

    Infusion rate 0.3 mg/kg/hr over 100 minutes (≈0.5 mg/kg total per infusion); continuation-phase weekly x4 for remitters; ketalar (brand).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.
  • Ability to provide informed consent
  • Male/Female
  • Age 18-65 yrs.
  • Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient Health Questionnaire-9 (PHQ-9) score ≥15 at hospital assessment
  • Treatment resistant depression (TRD) as defined by at least two previous antidepressant or mood stabilizing treatments for depression in adequate dose for 8 weeks
  • Patient reported overall suicide risk score ≥3 on the Suicide Status Form (SSF II-R) or score of ≥1 on Item 9 of PHQ-9 (all at admission assessment)
  • Ability to pass comprehension assessment test related to effects of ketamine and trial objectives and criteria
  • Voluntary admission

Exclusion Criteria

  • Exclusion Criteria:
  • Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis
  • Index episode of depression greater than 2 years
  • Ongoing prescription of ≥4 mg lorazepam equivalents total daily or a.m. dosing of any benzodiazepine at time of assessment
  • Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial magnetic stimulation as acute series or for maintenance
  • Any active or unstable medical condition as judged by principal investigator
  • Previous use or abuse of methamphetamine, cocaine, stimulants (prescribed and illicit) within past 12 months
  • Any current abuse or dependence of alcohol or drugs (except nicotine) and abuse or dependence of drugs and alcohol only in full remission (> 1 month, < 12 months). Patients will be allowed to enroll if their drug and alcohol abuse / dependence is in full (complete, not partial) sustained (> 1 year) remission.
  • History of traumatic brain injury
  • Developmental delay and intellectual disorder
  • Encephalopathy (clinical diagnosis within prior 12 months of delirium)
  • Cognitive disorder (mild and major)
  • Previous participation in earlier Ketamine trial
  • Pregnancy
  • Prisoners
  • Involuntarily hospitalized

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2014-01-09
    End: 2016-01-08
  • Compound
    Ketamine
  • Topic
    Depressive Disorders

Locations

Mayo Clinic — Rochester, Minnesota, United States

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