Ketamine for Depression and Suicide Risk

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study was to find out if the medication known as ketamine could help the symptoms of depression. This drug is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent; however, it is not approved for use in depression treatment. The FDA allowed the use of this drug in this research study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Ketamine

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 ≥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