Ketamine for Depression and Suicide Risk
Completed · Phase 2
Conditions studied: Depression, Suicide
In brief
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.
Key facts
- Study ID
- NCT02094898
- Run by
- Mayo Clinic
- People needed
- 12
- Starts
- 2014-09-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2017-08-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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