Acute and Maintenance Intravenous Ketamine for Treatment Resistant Major Depression With Suicidal Ideation/Attempt

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - Ability to provide informed consent - Current psychiatric inpatient at time of initiation of treatment. - Male/Female - Age 18-65 yrs. - Depressive episode (unipolar or bipolar I or II) with Patient Health Questionnaire-9 score >20 at initial hospital assessment - Treatment resistant depression as defined by at least two previous trials of antidepressants in adequate dose for 8 weeks - Patient reported overall suicide risk score ≥3 on the Suicide Status Form or score of 3 on Item 9 of Patient Health Questionnaire-9 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 - Currently using Gabapentin, Pregabalin, or Valproate or having used within 4 days - 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

Last updated:

3/20/2014

NCT ID:

NCT02094898

IRB Number:

13-005152