Sodium Oxybate as a Potential New Treatment for Catatonia in Patients With Depression, Bipolar Disorder, or a Psychotic Disorder: Protocol for a Randomized Controlled Trial
Abstract
Background Catatonia is a severe psychomotor syndrome predominantly associated with depressive, bipolar, and psychotic disorders. Untreated catatonia has a 10% mortality rate and may lead to complications such as renal failure, rhabdomyolysis, pneumonia, embolism, and contractures. High doses of the benzodiazepine lorazepam, a gamma-aminobutyric acid (GABA)-A receptor modulator, are the primary pharmacological treatment, enhancing GABA’s inhibitory effect, potentially reducing symptoms of catatonia. However, lorazepam is ineffective in about 25% of cases, leaving electroconvulsive therapy (ECT) as the only well-investigated alternative. Although often effective, ECT may have severe side effects and is not easily accepted among patients and caregivers. Therefore, there is an urgent need for novel therapies for catatonia. Sodium oxybate, a GABA precursor and GABA-B receptor agonist, is a promising alternative treatment based on observational data, but its efficacy has never been thoroughly investigated. Objective This study aims to evaluate the efficacy and safety of sodium oxybate in treating catatonia unresponsive to lorazepam, while also capturing the natural course and determinants of catatonia through an observational cohort. Methods The Laborit trial consists of a cohort study and an embedded single-blind randomized controlled trial (RCT). Patients with catatonia admitted to a psychiatric ward may join the study’s cohort, where their clinical characteristics are…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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