Ketamine for Depression and Suicide Risk
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-005152
NCT ID: NCT02094898
Sponsor Protocol Number: 13-005152
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Current psychiatric hospital inpatient at Mayo Clinic at time of initiation of treatment.
- Ability to provide informed consent
- 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
- 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
- Involuntarily hospitalized
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Mark Frye, M.D.
Contact us for the latest status