Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression

NCT02378415 | Terminated Phase 1

• 1 other identifier: NMCSD.2011.0063
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population. The study will pursue as a primary outcome measure whether a significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure will be assessed to determine whether this single infusion of ketamine has a sustained reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score. Suicidal ideation will also be assessed for determination of any reduction and sustained reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.

Conditions

Acute Depression

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• Suicidality

  Beck Suicidal Ideation Scale (BSS)

  Baseline

Secondary Outcomes (2)

• Depression

  Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks

• Hopelessness

  Baseline, 40-minutes, 80-minutes, 120-minutes, 240-minutes, exit at discharge, and at follow-up within 2-weeks

Study Arms (2)

Normal Saline Infusion

PLACEBO COMPARATOR

A single IV bolus dose of normal saline solution.

Drug: Placebo

Subanesthetic IV Bolus Ketamine

EXPERIMENTAL

a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality

Drug: Ketamine

Interventions

Ketamine DRUG

IV Bolus dose of ketamine dosed at 0.2mg/kg infused over 1-2 minutes.

Also known as: Ketalor.

Subanesthetic IV Bolus Ketamine

Placebo DRUG

Normal Saline Infusion

Normal Saline Infusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BSS greater than 4
• BHS greater than 8
• BDI greater than 19
• Ability to give informed consent.
• Active Duty military status.
• Verified negative qualitative pregnancy test.
• All participants must be accepted for psychiatric admission to the hospital PRIOR to consideration for enrollment in this study.

You may not qualify if:

• Psychosis or Bipolar Disorder.
• Pregnancy
• Involuntary Status on presentation to the ED.
• UDS positive for illicit drugs of abuse.
• Blood Alcohol level greater than zero.
• Previous enrollees in this treatment protocol will be excluded from repeat participation.
• Any patient brought for command directed psychiatric evaluation.
• Specific contraindications to the use of ketamine are as follows and under such circumstances or conditions, personnel with the following should be excluded from participation in this study:
• Patients with elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, CHF, a recent history of head or eye injury, or angina.
• All personnel in whom a significant elevation of blood pressure would constitute a serious hazard to their overall health and well-being.
• Patients currently utilizing the following medications: conivaptan, Disatinib, peginterferon alfa-2b, quazepam, tocilizumab

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Robert E Lovern, MD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: March 4, 2015
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 4, 2015

Record last verified: 2015-02

Locations

US (1)