Ketamine for Treatment-Resistant Bipolar Disorder

This Phase II interventional trial (n=100) will assess the efficacy, safety, and tolerability of repeated sub-anaesthetic doses of intravenous ketamine for the treatment of moderate to severe treatment-resistant bipolar disorder (TRBD).

Conducted by the University Health Network, Toronto, the study aims to determine the acute antidepressant effects of four flexibly-dosed adjunctive ketamine infusions over two weeks. Participants, aged 21 to 65, diagnosed with Bipolar I or II Disorder and experiencing a Major Depressive Episode without psychotic features, will receive either ketamine or midazolam infusions.

The primary outcome measure will be the change in depression severity assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) scores after two weeks. Secondary outcomes include evaluating response and remission rates, safety, tolerability, effects on suicidality, anxiety, quality of life, function, and duration of effects. Recruitment began in April 2022, with an estimated completion date of April 2024.

Topic Bipolar Disorder Depression
Compound Ketamine
Country Canada
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Sponsors & Collaborators

University Health Network Toronto
University Health Network is a public research and teaching hospital network in Toronto. The Nikean Psychedelic Psychotherapy Research Centre was established in 2021.

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