NCT04640636Felfüggesztve4. fázis
IM Ketamine vs Midazolam for Suicidal ER Patients
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 26.
Megadott ok: The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
Rövid összefoglaló (regiszter, angolul)
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement. NOTE: The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023. The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023. Non-HHS Studies: The IO in concurrence with the IRB paused human subjects research on June 12, 2023. Therefore, the NYSPI site is not enrolling at this time.
- Állapot (regiszter)
- Felfüggesztve
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tervezett)
- Első benyújtás
- 2020. nov. 20.
- Kezdés
- 2021. febr. 9.
- Elsődleges befejezés
- 2027. szept.
- Fő szponzor
- New York State Psychiatric Institute
- Betegségek
- Depresszió, Bipoláris zavar
- NCT-szám
- NCT04640636
Ki nem vehet részt
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Más betegség
- Substance use disorder in past 2 weeks
- Unstable medical or neurological illness such as uncontrolled hypertension, significant cardiac arrhythmia, unstable cerebrovascular disease. Chronic, stable medical conditions such as controlled hypertension or diabetes will not be excluded.
Egyéb
- Current psychosis or mania
- Intellectual disability
- Inadequate understanding of English and/or lack of capacity for informed consent
- Pregnancy or lactation
- Medical contraindication to ketamine or midazolam
Kiket keres a vizsgálat
- DSM5 unipolar or bipolar (I, II, or Unspecified) major depressive episode
- Presenting to emergency department and assessed by psychiatrist staff as needing inpatient treatment due to suicidality
- Participant agrees to voluntary inpatient psychiatric admission
- Beck Scale for Suicidal Ideation score of 4 or higher
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Comprehensive Psychiatric Emergency Department of Columbia University Medical Center | New York | Egyesült Államok | Ismeretlen állapot |
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