Ketamine for Depression and Suicide Risk

Overview

Información sobre este estudio

Study hypothesis: Do serial low-dose ketamine infusions, followed by weekly maintenance infusions, increase the length of time depressive symptoms stay in remission and the length of time associated suicide risk is improved? Brief Summary: This open label clinical trial is intended to further clarify initial response to low-dose ketamine infusion with repeated dosing and maintenance treatment model. Primary outcomes will be reduction in depression severity and reduction of suicide risk along with duration of response.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.
  • Ability to provide informed consent
  • Male/Female
  • Age 18-65 yrs.
  • Major Depressive Disorder or Bipolar Disorder I or Bipolar Disorder II with Patient Health Questionnaire-9 (PHQ 9) score ≥15 at hospital assessment
  • Treatment resistant depression (TRD) as defined by at least two previous antidepressant or mood stabilizing treatments for depression in adequate dose for 8 weeks
  • Patient reported overall suicide risk score ≥3 on the Suicide Status Form (SSF II-R) or score of ≥1on Item 9 of PHQ-9 (all at admission assessment)
  • Ability to pass comprehension assessment test related to effects of ketamine and trial objectives and criteria
  • Voluntary admission

Exclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder, or active psychosis
  • Index episode of depression greater than 2 years
  • Ongoing prescription of ≥4 mg lorazepam equivalents total daily or a.m. dosing of any benzodiazepine at time of assessment
  • Currently undergoing electroconvulsive therapy, deep brain stimulation or transcranial magnetic stimulation as acute series or for maintenance
  • Any active or unstable medical condition as judged by principal investigator
  • Previous use or abuse of methamphetamine, cocaine, stimulants (prescribed and illicit) within past 12 months
  • Any current abuse or dependence of alcohol or drugs (except nicotine) and abuse or dependence of drugs and alcohol only in full remission (> 1 month, < 12 months). Patients will be allowed to enroll if their drug and alcohol abuse / dependence is in full (complete, not partial) sustained (> 1 year) remission.
  • History of traumatic brain injury
  • Developmental delay and intellectual disorder
  • Encephalopathy (clinical diagnosis within prior 12 months of delirium)
  • Cognitive disorder (mild and major)
  • Previous participation in earlier Ketamine trial
  • Pregnancy
  • Prisoners
  • Involuntarily hospitalized

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

William Bobo, M.D., M.P.H.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20117956

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