A Study to Decrease Suicidal Thinking Using Ketamine

NCT02418702 | Withdrawn Phase 3 DMC

• 1 other identifier: NMCSD.2014.0031
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Depression treatment typically is slow acting. Patients presenting with acute suicidality have few immediate treatment options. However, sub-anesthetic doses of ketamine have been now widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale showed this could be applied to suicidal patients, with 14 of 15 participants showing remission of suicidal thinking within 40 min of the administration of ketamine, with 13 showing lasting remission out to 10 days. No serious side effects were reported. This project proposes to conduct a randomized, placebo-controlled trial of this, same intervention in military patients recently hospitalized for suicidal thinking. After being assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine or placebo. Their suicidal thinking, depression, and other symptoms would be monitored acutely for 240 min after drug infusion, and the for lasting changes the next day, at hospital discharge, 2 weeks, and 10 weeks. Potential adverse events will be monitored via the electronic medical record for up to a year.

Conditions

Depression; Suicide

Keywords

depression; suicide; ketamine; rapid intravenous bolus; sub-anesthetic dose; double-blind placebo control

Outcome Measures

Primary Outcomes (3)

• Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)

  measure whether a significant reduction in depressive symptoms, as assessed by the BSS, BHS, and BDI occurs shortly after administration of ketamine

  baseline and 240 minutes

• Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)

  baseline and 2 weeks

• Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)

  baseline and 10 weeks

Secondary Outcomes (3)

• Reduction in suicidal thinking measured by BSS, BHS, and BDI

  1 day post-infusion

• Reduction in suicidal thinking measured by BSS, BHS, and BDI

  2 weeks post-infusion

• Reduction in suicidal thinking measured by BSS, BHS, and BDI

  10 weeks post-infusion

Study Arms (2)

0.2mg/kg ketamine

EXPERIMENTAL

After being assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine. Their suicidal thinking, depression, and other symptoms would be monitored acutely for 240 min after drug infusion, and the for lasting changes the next day, at hospital discharge, 2 weeks, and 10 weeks.

Drug: 0.2 mg/kg ketamine

placebo

PLACEBO COMPARATOR

After being assessed, and giving informed consent, participants would receive a placebo. Symptoms will be monitored.

Other: placebo

Interventions

0.2 mg/kg ketamine DRUG

20 patients will randomly be assigned 0.2 mg/kg of Ketamine

Also known as: Ketamine

0.2mg/kg ketamine

placebo OTHER

20 patients will randomly be assigned a placebo

placebo

Eligibility Criteria

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

You may qualify if:

• Voluntarily, psychiatrically hospitalized at NMCSD within the last 12 hours for suicidal thinking
• BSS greater than 4
• BHS greater than 8
• BDI greater than 19
• Ability to give informed consent
• Active duty military status
• Verified negative pregnancy test for females

You may not qualify if:

• Psychosis or bipolar disorder
• Pregnancy
• Involuntary status on presentation to the ED
• 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 contraindication 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:
• A) patients with elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, congestive heart failure (CHF), a recent history of head or eye injury, or angina B) all personnel in whom a significant elevation of blood pressure would constitute a serious hazard to their overall health and well-being C) patients currently utilizing the following medications: conivaptan, dasatinib, 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

Related Publications (8)

• Melville NA. Bolus dose of ketamine offers fast-acting alleviation of acute depression in ED setting. Medscape Medical News. September 29, 2010.

  BACKGROUND

• Messer MM, Haller IV. Maintenance ketamine treatment produces long-term recovery from depression. Primary Psychiatry. 2010; 17(4):48-50.

  BACKGROUND

• Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.

  PMID: 16894061 BACKGROUND

• Yilmaz A, Schulz D, Aksoy A, Canbeyli R. Prolonged effect of an anesthetic dose of ketamine on behavioral despair. Pharmacol Biochem Behav. 2002 Jan-Feb;71(1-2):341-4. doi: 10.1016/s0091-3057(01)00693-1.

  PMID: 11812542 BACKGROUND

• Sanacora G, Gueorguieva R, Epperson CN, Wu YT, Appel M, Rothman DL, Krystal JH, Mason GF. Subtype-specific alterations of gamma-aminobutyric acid and glutamate in patients with major depression. Arch Gen Psychiatry. 2004 Jul;61(7):705-13. doi: 10.1001/archpsyc.61.7.705.

  PMID: 15237082 BACKGROUND

• Zarate CA Jr, Du J, Quiroz J, Gray NA, Denicoff KD, Singh J, Charney DS, Manji HK. Regulation of cellular plasticity cascades in the pathophysiology and treatment of mood disorders: role of the glutamatergic system. Ann N Y Acad Sci. 2003 Nov;1003:273-91. doi: 10.1196/annals.1300.017.

  PMID: 14684452 BACKGROUND

• Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.

  PMID: 10686270 BACKGROUND

• Panzer O, Moitra V, Sladen RN. Pharmacology of sedative-analgesic agents: dexmedetomidine, remifentanil, ketamine, volatile anesthetics, and the role of peripheral mu antagonists. Crit Care Clin. 2009 Jul;25(3):451-69, vii. doi: 10.1016/j.ccc.2009.04.004.

  PMID: 19576524 BACKGROUND

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

Study Officials

• Marc A Capobianco

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 16, 2015
• Study Start: August 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

US (1)