This open-label pilot study (n=30) aims to examine the effect of intravenous (IV) ketamine treatment on acute suicidality (SI) in patients with bipolar depression (BD).
Conducted by the Centre for Addiction and Mental Health, the study investigates the neurophysiological mechanisms of ketamine’s action directly from the cortex in BD patients experiencing suicidal thoughts. Ketamine, acting as an N-methyl-d-aspartate (NMDA) receptor antagonist, is administered over 40-minute IV infusions twice per week for four weeks.
The primary outcome measures include assessing the impact of IV ketamine on cortical excitation and inhibition using Transcranial Magnetic Stimulation (TMS) paired with electromyography (EMG) and electroencephalography (EEG).
Secondary outcome measures include changes in suicidal ideation and depressive symptoms. Safety and tolerability are also evaluated through monitoring vital signs and adverse events. The study aims to provide insights into ketamine’s anti-suicidal effects and its potential as an innovative treatment for BD-related suicidality.
Trial Details
Bipolar disorder is characterized by manic episodes and episodes of extreme depressive feelings, also known as bipolar depression (BD). Although clinical data does not suggest significant differences in the severity of depressive symptoms between bipolar and unipolar depression, patients with BD are found to be more likely to experience suicidal ideation and suicide attempts. Innovative treatments for suicidality in patients with BD are needed to address tolerability and slow effect limitations of current interventions. Using an open label pilot study, this trial aims to examine the effect of Intravenous (IV) ketamine treatment on acute suicidality in patients with BD. Moreover, the study aims to explore the neurophysiological mechanisms of ketamine's action directly from the cortex in patients with BD, in order to understand the biological mechanism underlying ketamine's therapeutic action.Trial Number NCT05177146