A Phase II randomised double blind, placebo-controlled trial of oral ketamine as an augmentation treatment for treatment resistant bipolar II depression

Our project will conduct the largest phase II randomised clinical trial of ketamine in adults with bipolar depression, to assess the safety and preliminary efficacy of abuse-deterrent oral ketamine in underserved patient population. Bipolar depression II (BD-II), characterized by recurrent episodes of hypomania and depression, is a prevalent subtype of bipolar disorder (BD). Up to 1 of 4 BD-II cases are treatment-resistant (TRBD-II), where prior courses of therapy fail repeatedly. While low doses of the anesthetic ketamine have shown rapid and robust antidepressant effects in adults with TRBD-II, no comprehensive, systematic clinical studies of this intervention have been conducted. Meanwhile, access to intravenous or intranasal ketamine in general is limited by safety, financial and logistical challenges. Given these unmet clinical needs in TRBD-II, Neurocentrx has developed a novel abuse-deterrent capsule formulation of oral ketamine. Our clinical study can confirm whether abuse-deterrent oral ketamine may provide a new effective treatment option for TRBD-II. We will also validate a new clinical care protocol for oral ketamine, where administration starts in clinics and then transitions to home treatment settings. In total, our proposal can help provide a new treatment approach to improve accessibility and expand treatment options for TRBD-II patients.