Conditions: Bipolar Disorder
Keywords: Bipolar Disorder Depression Treatment-Resistant ketamine antidepressant glutamate
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 1
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.

Detailed description:
Bipolar disorder (BPD) is a common, recurrent, and disabling medical condition. Although mania is the defining feature of BPD, depression represents the majority of illness burden in patients with this devastating condition. Despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. Recently, a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. Therefore, the objective of the current study is to investigate the safety and efficacy of a single IV dose of ketamine in treatment-resistant bipolar depression (TRBD).

Arms:
arm 1: Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to ketamine-midazolam. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart. arm 2: Patients receive both treatment conditions (ketamine and midazolam) in a single arm, crossover design. Patients are randomized to midazolam-ketamine. Each treatment occurs as a single intravenous infusion on one treatment day. The two treatment conditions occur 2 weeks apart.

Interventions: intervention 1: ketamine intervention 2: midazolam
Intervention descriptions: intervention 1: a single IV infusion of ketamine, IV 0.5 mg/kg intervention 2: a single IV infusion of midazolam, 0.045 mg/kg

Protocol document: