This Phase IV interventional trial (n=1500) aims to compare the effectiveness of electroconvulsive therapy (ECT) versus subanesthetic dose intravenous ketamine (KET) for the treatment of Acute Suicidal Depression (ASD).
Conducted by Brigham and Women’s Hospital in collaboration with several other institutions, including Johns Hopkins University and the University of Pittsburgh, the study addresses the urgent need for effective treatment for ASD, a life-threatening condition with inadequate treatment options.
The trial will involve participants aged 18 to 90 years referred for ECT treatment, meeting DSM-5 criteria for Major Depressive Episode (MDE), and expressing suicidal intent. Patients will be randomly assigned to receive either standard dose ketamine infusion or ECT three times a week for up to 4 weeks.
The primary outcome measure will be assessed using the Scale for Suicidal Ideation (SSI), with secondary measures including Quick Inventory of Depressive Symptoms Self Report (QIDS-SR), Columbia Suicide Severity Rating Scale (CSSR-S), and Montgomery Asberg Depression Rating Scale (MADRS), among others.
The study aims to provide evidence-based guidance for clinicians, patients, and healthcare administrators in choosing the most effective treatment for ASD, ultimately improving patient outcomes and reducing the risk of repeat suicide attempts.
Trial Details
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).Trial Number NCT06034821
Sponsors & Collaborators
Brigham and Womens HospitalThis company doesn't have a full profile yet, it is linked to a clinical trial.
Johns Hopkins University
Johns Hopkins University (Medicine) is host to the Center for Psychedelic and Consciousness Research, which is one of the leading research institutes into psychedelics. The center is led by Roland Griffiths and Matthew Johnson.
University of Pittsburgh
This company doesn't have a full profile yet, it is linked to a clinical trial.