Ketamine for Depression and Suicide Risk

NCT ID: NCT02094898

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

Brief 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.

Detailed Description

This was a single-arm, open-label trial conducted in two phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission (Montgomery Åsberg Depression Rating Scale (MÅDRS)) total score less than or equal to 9 measured 24h after any acute-phase infusion) received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.Those who responded to i.v. ketamine (less than or equal to 50% reduction from baseline in MÅDRS total score) but did not remit during acute-phase were not eligible for continuation-phase treatment. Suicidal ideation was assessed clinically throughout the trial, supplemented by scores on the MÅDRS suicide item.

Conditions

Depression; Suicide

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine infusion

This trial was conducted in 2 phases. During the acute-phase, i.v. ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive symptom remission received continuation-phase treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks. Remission could occur after any of the 6 acute-phase infusions, at which point the next infusion was the first (of four) continuation-phase infusions. Individuals who remitted during acute-phase and completed continuation-phase treatment had 4 additional weekly post-continuation follow-up visits.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

0.3 mg/kg/hr of ketamine infused for 100 minutes

Interventions

Ketamine

0.3 mg/kg/hr of ketamine infused for 100 minutes

Intervention Type: DRUG

Other Intervention Names

Ketalar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

William V. Bobo, M.D.

Consultant - Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William V Bobo, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant - Psychiatry

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Vande Voort JL, Morgan RJ, Kung S, Rasmussen KG, Rico J, Palmer BA, Schak KM, Tye SJ, Ritter MJ, Frye MA, Bobo WV. Continuation phase intravenous ketamine in adults with treatment-resistant depression. J Affect Disord. 2016 Dec;206:300-304. doi: 10.1016/j.jad.2016.09.008. Epub 2016 Sep 12.

Reference Type: RESULT

PMID: 27656788 (View on PubMed)

Other Identifiers

13-005152

Identifier Type: -

Identifier Source: org_study_id