Ketamine for Depression and Suicide Risk

NCT02094898 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 13-005152
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Suicide

Keywords

Depression; Unipolar; Bipolar; Suicidal

Outcome Measures

Primary Outcomes (1)

• MADRS Total Score at Baseline and Last Acute Phase Observation

  The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.

  baseline, last acute phase observation (approximately 2 weeks)

Secondary Outcomes (13)

• MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation

  baseline, last acute phase observation (approximately 2 weeks)

• MADRS Factor 1 Score at Baseline and Last Acute Phase Observation

  baseline, last acute phase observation (approximately 2 weeks)

• MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation

  baseline, last acute phase observation

• MADRS Factor 2 Score at Baseline and Last Acute Phase Observation

  baseline, last acute phase observation (approximately 2 weeks)

• MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation

  baseline, last acute phase observation (approximately 2 weeks)

Study Arms (1)

Ketamine infusion

EXPERIMENTAL

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.

Drug: Ketamine

Interventions

Ketamine DRUG

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

Also known as: Ketalar

Ketamine infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 27656788 RESULT

MeSH Terms

Conditions

Depression; Suicide

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Lack of placebo or other control group and small sample size.

Results Point of Contact

• Title: William V. Bobo, M.D.
• Organization: Mayo Clinic

Bobo.William@mayo.edu

507-538-9041

Study Officials

• William V Bobo, MD

  Consultant - Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant - Psychiatry

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 24, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 11, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-08

Locations

US (1)