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Treatment of Suicidal Ideation With Intravenous Ketamine Infusion

7. april 2017 opdateret af: Dr. Richard Shelton, University of Alabama at Birmingham
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, we are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression. Patients will be asked to participate in a research study to study how the use of a medication, ketamine, decreases your suicidal thoughts and improves their symptoms of depression. Ketamine is approved by FDA for use at higher doses in anesthesia, and recent clinical research suggests that it might benefit patients with major depressive disorder and suicidal thoughts. During clinical trials with over 10,000 patients, ketamine was proved to be safe as an anesthetic and studies with hundreds of patients with depression have demonstrated safety and lack of lasting side effects. This is a pilot study to test a new use of ketamine: treatment of suicidal thoughts. The study medication will be given in addition to usual psychiatric care.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35205
        • University of Alabama Birmingham

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age : 19-64
  2. Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS)
  3. Willing and able to provide informed consent.
  4. Individuals with current substance abuse are allowed

Exclusion Criteria:

  1. Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method)
  2. Post-Partum state : defined as being within 2 months of delivery or miscarriage
  3. Homicide risk as determined by clinical interview
  4. Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium)
  5. Any known hypersensitivity or serious adverse effect associated with ketamine treatment.
  6. Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina
  7. Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment.

  8. Any of the following DSM-IV diagnoses or categories:

    • Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia)
    • Currently in a manic or mixed episode
    • Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine
    • Any dissociative disorder
    • Any pervasive developmental disorder (e.g., autism)
    • A cognitive disorder (e.g., Alzheimer's Disease)
    • Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included
    • Any eating disorder

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Suicidal, Depression with Ketamine
suicidal ideation and depression (no substance use disorder) 0.2 mg/kg IV ketamine administered as a one time dose
Medicin: Ketamine
single dose IV 0.2 mg/kg ketamine
Placebo komparator: Suicidal, Depression with Saline
Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline)
Medicin: placebo
saline infusion
Andre navne:
  • saltvand
Aktiv komparator: Suicidal, opioid use with ketamine
suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
Medicin: Ketamine
single dose IV 0.2 mg/kg ketamine
Placebo komparator: Suicidal, opioid use with Saline
Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
Medicin: placebo
saline infusion
Andre navne:
  • saltvand

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Suicidality
Tidsramme: 2 hours

Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation.

Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.
2 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression
Tidsramme: 2 hours
Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60
2 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Alabama at Birmingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2012

Primær færdiggørelse (Faktiske)

1. januar 2014

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

7. august 2012

Først indsendt, der opfyldte QC-kriterier

26. juni 2013

Først opslået (Skøn)

27. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F120307001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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