Feasibility of oral ketamine for bipolar depression: a 20-week open-label study

This open-label Phase II trial (n=30) will investigate the feasibility, safety, and antidepressant effects of oral ketamine (starting at 1 mg/kg, up to 2 mg/kg) in adults with bipolar depression.

Conducted by the University of Otago in New Zealand, the study will administer oral ketamine twice weekly for up to 8 weeks under clinical supervision. Dosing begins at 1 mg/kg, mixed with juice and consumed over 30–60 minutes, and may increase based on tolerability and depressive symptom scores, as assessed by the Montgomery–Åsberg Depression Rating Scale (MADRS). If patients show significant symptom reduction, dosing frequency may be lowered to weekly.

The primary goal is to assess feasibility based on recruitment, retention, and adherence rates, as well as improvements in depressive symptoms. Secondary outcomes will evaluate relapse prevention, cognitive functioning, quality of life, and potential for ketamine dependence. Participants will be monitored for safety using clinical assessments for dissociation, mood elevation (via the Young Mania Rating Scale), and bladder symptoms. The study aims to address the gap in treatment options for bipolar depression using a more accessible and potentially scalable oral formulation of ketamine.

Topic Bipolar Disorder Depression Treatment-Resistant Depression
Compound Ketamine
Country New Zealand
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