ED Treatment of Suicidal Patients With Ketamine Infusion

NCT03502551 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 1197884
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine if a single intravenous (IV) dose of ketamine given in the emergency department (ED) can provide a long term reduction in suicidal ideation, lower time to ED discharge, and increase discharge to home or voluntary treatment facilities all while being safe.

Conditions

Suicide; Suicidal Ideation

Keywords

ketamine; suicide

Outcome Measures

Primary Outcomes (3)

• Suicidal ideation at 24 hours post-infusion

  Suicidal ideation as measured by the Montgomery-Asberg Depression Scale (MARDS) will be assessed at 24 hours post-infusion of ketamine. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression.

  24 hours post-infusion

• Incidence of Discharge to Outpatient vs. Inpatient Facilities

  The investigators will collect information about what location patients enrolled in this study are discharged to (E.g. home, outpatient crisis residential facility, inpatient psychiatric hospital, admission to general hospital).

  Through ED stay, an average of 53 hours

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Patients will be monitored for adverse events during the course of this study.

  1 week from enrollment.

Secondary Outcomes (4)

• Overall MARDS score

  1 hour, 3 days, and 1 week post-infusion

• MARDS Suicidal Ideation (MARDS-SI) score

  1 hour, 3 days, and 1 week post-infusion

• Scale for Suicide Ideation-5 (SSI5) score

  1 hour, 3 days, and 1 week post-infusion

• ED length of stay

  Through ED stay, an average of 53 hours

Study Arms (1)

Treatment with Ketamine

EXPERIMENTAL

In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes.

Drug: Ketamine

Interventions

Ketamine DRUG

Ketamine infusion (0.5 mg/kg) over 40 minutes.

Also known as: Ketalar

Treatment with Ketamine

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Chief complaint of suicidal thoughts with a MADRS-SI score \> 3
• Major depressive episode with MADRS \> 19 (moderate to severe)

You may not qualify if:

• Pregnancy
• Psychosis
• Acute intoxication with alcohol or illicit drugs
• Acute withdrawal from alcohol or illicit drugs
• Adults otherwise unable to consent
• Concurrent, active medical illness requiring medical hospitalization
• Inability to follow-up including no permanent address or valid telephone number
• Patients unable to attend outpatient follow-up (no medical insurance, refusal to follow-up, no established care provider)
• Specific contraindication to the use of ketamine (concern for increased intracranial or intraocular pressure, known allergy to ketamine)
• Greater than 12 hours from time of ED presentation
• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (20)

• Price RB, Iosifescu DV, Murrough JW, Chang LC, Al Jurdi RK, Iqbal SZ, Soleimani L, Charney DS, Foulkes AL, Mathew SJ. Effects of ketamine on explicit and implicit suicidal cognition: a randomized controlled trial in treatment-resistant depression. Depress Anxiety. 2014 Apr;31(4):335-43. doi: 10.1002/da.22253. Epub 2014 Mar 25.

  PMID: 24668760 BACKGROUND

• Zarate CA Jr, Brutsche NE, Ibrahim L, Franco-Chaves J, Diazgranados N, Cravchik A, Selter J, Marquardt CA, Liberty V, Luckenbaugh DA. Replication of ketamine's antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry. 2012 Jun 1;71(11):939-46. doi: 10.1016/j.biopsych.2011.12.010. Epub 2012 Jan 31.

  PMID: 22297150 BACKGROUND

• DiazGranados N, Ibrahim LA, Brutsche NE, Ameli R, Henter ID, Luckenbaugh DA, Machado-Vieira R, Zarate CA Jr. Rapid resolution of suicidal ideation after a single infusion of an N-methyl-D-aspartate antagonist in patients with treatment-resistant major depressive disorder. J Clin Psychiatry. 2010 Dec;71(12):1605-11. doi: 10.4088/JCP.09m05327blu. Epub 2010 Jul 13.

  PMID: 20673547 BACKGROUND

• Murrough JW, Soleimani L, DeWilde KE, Collins KA, Lapidus KA, Iacoviello BM, Lener M, Kautz M, Kim J, Stern JB, Price RB, Perez AM, Brallier JW, Rodriguez GJ, Goodman WK, Iosifescu DV, Charney DS. Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial. Psychol Med. 2015 Dec;45(16):3571-80. doi: 10.1017/S0033291715001506. Epub 2015 Aug 12.

  PMID: 26266877 BACKGROUND

• Zhu JM, Singhal A, Hsia RY. Emergency Department Length-Of-Stay For Psychiatric Visits Was Significantly Longer Than For Nonpsychiatric Visits, 2002-11. Health Aff (Millwood). 2016 Sep 1;35(9):1698-706. doi: 10.1377/hlthaff.2016.0344.

  PMID: 27605653 BACKGROUND

• Godwin SA, Burton JH, Gerardo CJ, Hatten BW, Mace SE, Silvers SM, Fesmire FM; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2014 Feb;63(2):247-58.e18. doi: 10.1016/j.annemergmed.2013.10.015.

  PMID: 24438649 BACKGROUND

• Hopper AB, Vilke GM, Castillo EM, Campillo A, Davie T, Wilson MP. Ketamine use for acute agitation in the emergency department. J Emerg Med. 2015 Jun;48(6):712-9. doi: 10.1016/j.jemermed.2015.02.019. Epub 2015 Apr 2.

  PMID: 25843924 BACKGROUND

• Miner JR, Moore JC, Austad EJ, Plummer D, Hubbard L, Gray RO. Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department. Ann Emerg Med. 2015 May;65(5):479-488.e2. doi: 10.1016/j.annemergmed.2014.08.046. Epub 2014 Oct 16.

  PMID: 25441247 BACKGROUND

• Patanwala AE, McKinney CB, Erstad BL, Sakles JC. Retrospective analysis of etomidate versus ketamine for first-pass intubation success in an academic emergency department. Acad Emerg Med. 2014 Jan;21(1):87-91. doi: 10.1111/acem.12292.

  PMID: 24552528 BACKGROUND

• Sin B, Ternas T, Motov SM. The use of subdissociative-dose ketamine for acute pain in the emergency department. Acad Emerg Med. 2015 Mar;22(3):251-7. doi: 10.1111/acem.12604. Epub 2015 Feb 25.

  PMID: 25716117 BACKGROUND

• Grossimlinghaus I, Falkai P, Gaebel W, Hasan A, Janner M, Janssen B, Reich-Erkelenz D, Gruber L, Bottcher V, Wobrock T, Zielasek J; LVR-Klinikverbund. [Assessment of quality indicators with routine data: Presentation of a feasibility test in ten specialist clinics for psychiatry and psychotherapy]. Nervenarzt. 2015 Nov;86(11):1393-9. doi: 10.1007/s00115-015-4357-y. German.

  PMID: 26122639 BACKGROUND

• American College of Emergency Physicians Clinical Policies Subcommittee (Writing Committee) on the Adult Psychiatric Patient; Nazarian DJ, Broder JS, Thiessen MEW, Wilson MP, Zun LS, Brown MD. Clinical Policy: Critical Issues in the Diagnosis and Management of the Adult Psychiatric Patient in the Emergency Department. Ann Emerg Med. 2017 Apr;69(4):480-498. doi: 10.1016/j.annemergmed.2017.01.036. No abstract available.

  PMID: 28335913 BACKGROUND

• Pourmand A, Mazer-Amirshahi M, Royall C, Alhawas R, Shesser R. Low dose ketamine use in the emergency department, a new direction in pain management. Am J Emerg Med. 2017 Jun;35(6):918-921. doi: 10.1016/j.ajem.2017.03.005. Epub 2017 Mar 2.

  PMID: 28285863 BACKGROUND

• Lee EN, Lee JH. The Effects of Low-Dose Ketamine on Acute Pain in an Emergency Setting: A Systematic Review and Meta-Analysis. PLoS One. 2016 Oct 27;11(10):e0165461. doi: 10.1371/journal.pone.0165461. eCollection 2016.

  PMID: 27788221 BACKGROUND

• Scaggs TR, Glass DM, Hutchcraft MG, Weir WB. Prehospital Ketamine is a Safe and Effective Treatment for Excited Delirium in a Community Hospital Based EMS System. Prehosp Disaster Med. 2016 Oct;31(5):563-9. doi: 10.1017/S1049023X16000662. Epub 2016 Aug 12.

  PMID: 27517801 BACKGROUND

• Jennings PA, Cameron P, Bernard S. Ketamine as an analgesic in the pre-hospital setting: a systematic review. Acta Anaesthesiol Scand. 2011 Jul;55(6):638-43. doi: 10.1111/j.1399-6576.2011.02446.x. Epub 2011 May 16.

  PMID: 21574967 BACKGROUND

• Ballard ED, Luckenbaugh DA, Richards EM, Walls TL, Brutsche NE, Ameli R, Niciu MJ, Vande Voort JL, Zarate CA Jr. Assessing measures of suicidal ideation in clinical trials with a rapid-acting antidepressant. J Psychiatr Res. 2015 Sep;68:68-73. doi: 10.1016/j.jpsychires.2015.06.003. Epub 2015 Jun 16.

  PMID: 26228403 BACKGROUND

• Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979 Apr;134:382-9. doi: 10.1192/bjp.134.4.382.

  PMID: 444788 BACKGROUND

• Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide Ideation. J Consult Clin Psychol. 1979 Apr;47(2):343-52. doi: 10.1037//0022-006x.47.2.343. No abstract available.

  PMID: 469082 BACKGROUND

• McGirr A, Berlim MT, Bond DJ, Fleck MP, Yatham LN, Lam RW. A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med. 2015 Mar;45(4):693-704. doi: 10.1017/S0033291714001603. Epub 2014 Jul 10.

  PMID: 25010396 BACKGROUND

MeSH Terms

Conditions

Suicide; Suicidal Ideation

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Aimee Moulin, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: April 18, 2018
• Study Start: April 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)