Ketamine for Depression and Suicide Risk


About this study

Study hypothesis: Do serial low-dose ketamine infusions, followed by weekly maintenance infusions, increase the length of time depressive symptoms stay in remission and the length of time associated suicide risk is improved? Brief Summary: This open label clinical trial is intended to further clarify initial response to low-dose ketamine infusion with repeated dosing and maintenance treatment model. Primary outcomes will be reduction in depression severity and reduction of suicide risk along with duration of response.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 ≥1on 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:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

William Bobo, M.D., M.P.H.

Closed for enrollment

More information


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