NCT02997722

Brief Summary

This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 2, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 29, 2020

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

December 15, 2016

Results QC Date

April 16, 2020

Last Update Submit

May 18, 2020

Conditions

Suicidal Ideation

Keywords

ketaminesuicidal ideationlength of stay

Outcome Measures

Primary Outcomes (1)

  • Inpatient Hospital Length of Stay

    We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.

    The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.

Study Arms (2)

Ketamine infusion

EXPERIMENTAL

Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.

Drug: Ketamine

Normal Saline infusion

PLACEBO COMPARATOR

Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.

Drug: Normal Saline

Interventions

KetamineDRUG

IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.

Ketamine infusion
Normal SalineDRUG

IV infusion of 100 ml of normal saline over 45 minutes.

Normal Saline infusion

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women between the ages of 18 and 64
  • Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations

You may not qualify if:

  • Lifetime history of schizophrenia or other primary psychotic disorder
  • Current psychotic or manic symptoms
  • Substance use disorder within one month of admission
  • Positive urine toxicology at admission
  • Any lifetime abuse of ketamine or phencyclidine
  • Systolic BP \>180 mmHg or diastolic BP \>110 mmHg
  • Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion
  • Known central nervous system (CNS) mass
  • CNS abnormalities
  • Hydrocephalus
  • Glaucoma
  • Acute globe injury
  • Porphyria
  • Untreated thyroid disease
  • Known coronary artery disease with poor functional capacity
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Interventions

KetamineSaline Solution

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

The small number of subjects (i.e., only 4) recruited prior to the premature termination of this study prevents one from drawing meaningful conclusions from this data.

Results Point of Contact

Title
Allen Richert, MD
Organization
University of Mississippi Medical Center
arichert@umc.edu
(601) 984-4820

Study Officials

  • Allen C Richert, MD

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Human Behavior

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 20, 2016

Study Start

March 2, 2017

Primary Completion

May 19, 2017

Study Completion

May 19, 2017

Last Updated

June 2, 2020

Results First Posted

April 29, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)