Sodium oxybate as a potential new treatment for catatonia in patients with depression, bipolar disorder or a psychotic disorder, a randomized controlled trial. The Laborit study

Amsterdam UMC Location VUmc0 个研究点目标入组 42 人开始时间: 2024年6月3日最近更新: 2024年7月22日

研究概览

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•1. Adult patients (age 18 years and over)
•2. Admition to an acute psychiatric ward for the treatment of catatonia, not responedingto usual care (i.e., increasing doses of lorazepam to a maximum of 24 mg during 4 days).
•3. DSM-5 classification of either unipolar depressive disorder, bipolar disorder or a psychotic disorder
•4. Catatonia is present for a maximum of eight weeks.

•1. Not able to take drugs orally, i.e., subjects who actively resist treatment, and are thus not able/or want to take oral sodium oxybate
•2. Somatic disorder underlying catatonia
•3. Use of anti-psychotic drugs if patients prior to the development of catatonia either had an increase or change in anti-psychotic medication. Patients that have been treated with a stable dose of antipsychotics for a longer period of time should be allowed to be treated further with anti-psychotic medication if the patient’s treating psychiatrist deems this necessary and catatonia is mild, i.e. BFRCS <9
•4. Known heart failure or renal impairment due to significant amounts of sodium in the sodium oxybate
•5. Known sleep apnoea.
•6.1. Use of GABAergic drugs including gabapentin, pregabalin and clonidine
•6.2. Use of GHB dehydrogenase inhibitors, including valproate, phenytoin and ethosuximide
•6.3. Use of opioids, except tramadol
•7. Presence of alcohol use disorder
•8. Presence of malignant catatonia (as is indicated by autonomic dysregulation, item 23 of the Bush Francis Catatonia rating scale, scoring 3 combined with moderately severe to severe muscle rigidity, item 11 of the Bush Francis Catatonia rating scale, scoring 2 or higher) or development of malignant catatonia during the study
•Patients with malignant catatonia need to receive treatment with ECT as soon as possible since mortality in those with untreated catatonia ranges between 10 and 40%

发起方

Amsterdam UMC Location VUmc