Skip to content
CompletedPhase 2Results posted

Ketamine for Depression and Suicide Risk

NCT02094898 · Ketamine · Mayo Clinic

Closed to entry
Status
Not accepting participants
Phase 2
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • MADRS Total Score at Baseline and Last Acute Phase Observation

    Measured over baseline, last acute phase observation (approximately 2 weeks)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Mayo ClinicRochesterMinnesotaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02094898 on ClinicalTrials.gov →

Last updated in the registry 2017-08-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits