Subanesthetic dose intravenous ketamine (KET): This trial will use standard dose of ketamine (0.5mg/kg infusion over 40 min period) in accordance with research studies that have used ketamine as an antidepressant. Treatments will be given two times a week for a maximum of 8 treatments during the acute arm of the study. The investigators will be able to modify dose and number of treatments as indicated clinically per pragmatic clinical trials procedures. Patients will be clinically assessed prior to each treatment to evaluate response and appropriateness of continuation of treatment. Per FDA guidelines a maximum 60mg/dose will be given regardless of body weight.
Electroconvulsive therapy (ECT): ECT will be given in a standard manner 3 times a week for 4 weeks. The Initial ECT treatment will be Right Unilateral (RUL) ultra-brief pulse at 6x seizure threshold determined during titration at first visit. If there is not satisfactory improvement with RUL the investigator may change to Bilateral (BL) utilizing brief pulse using 0.5 modified half-age method to determine stimulus intensity. The seizure threshold may increase during the course of treatment and the dose of the electric stimulus may need to be increased incrementally. It is suggested to change to bilateral after three to five RUL treatments if response to treatment is not satisfactory. Treatments will be given three times a week for up to 4 weeks.
Study summary
This study is a randomized open-label single-blind non-inferiority comparative effectiveness study of ECT vs. KET for the treatment of Acute Suicidal Depression (ASD).
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
1. Considered by a clinician as appropriate for referral to treatment services for rapid reversal of acute suicidal depression.
2. Adults 18 - 90 years of age.
3. Meet DSM-5 criteria for Major Depressive Episode (MDE) as determined by Mini International Neuropsychiatric Interview (MINI PLUS 5.0.0).
4. Acute suicidal ideation or behavior (thinking or behavior suggesting harming or hurting oneself with knowledge that death may result) or attempt (any intentional, non-fatal self-injury regardless of medical lethality, if intent to die was indicated). \*
5. Continue to express suicidal ideation since referral as evidenced by Scale for Suicidal Ideation (SSI) ≥6)\*\*
6. Meet the following criteria on symptom rating scales at screening:
1. Hamilton Depression Scale (HAM-D 17) \>15
2. Montreal Cognitive Assessment (MoCA) of ≥23(to rule out baseline significant cognitive impairment)
Exclusion Criteria:
1. Meeting DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder.
2. Not able to give informed consent to receive ECT or KET treatment.
3. Not able to give informed consent to participate in the study.
4. Meet exclusion criteria for ECT treatment as described in guidelines.
5. Meet exclusion criteria for KET treatment such as:
1. Pregnant or breast feeding
2. Satisfying DSM-V criteria of current Mood Depressive Disorder Episode with Psychotic Features (i.e. delusions of hallucinations)
3. Severe uncontrolled medical illness
4. Ketamine allergy
6. Intellectual disability and unable to provide consent or follow study procedures.
Primary outcome measure(s)
Scale for Suicidal Ideation (SSI) — Six weeks The Scale for Suicidal Ideation (SSI is excellent in terms of test construction and psychometrics (validity and reliability). It has been shown that a SSI score \>6 has been found to be predictive of suicide within 6 months of discharge from hospital. At the end of treatment, patients will be assessed for remission of suicidality which is defined as a SSI score \<4 i.e. no clinically significant suicidal ideation70. A stringent criterion for remission was chosen as ASD is a life-threatening illness and full remission should be the treatment goal.
Trial sites (10)
Facility
City
Region
Status
UC San Francisco
San Francisco
California
Johns Hopkins University
Baltimore
Maryland
McLean Hospital
Belmont
Massachusetts
Massachusetts General Hospital
Boston
Massachusetts
Mount Sinai School of Medicine
New York
New York
Cleveland Clinic
Cleveland
Ohio
University of Pittsburgh
Pittsburgh
Pennsylvania
UTHealth Houston
Houston
Texas
University of Utah
Salt Lake City
Utah
Center for Addiction and Mental Health (University of Toronto)
Toronto
Ontario
More Brigham and Women's Hospital trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.