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
Notice bibliographique
Résumé
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 recorded. Standard care, including lorazepam up to 24 mg/day, will be administered. On day 4, the Bush Francis Catatonia Rating Scale (BFCRS) will be used to measure symptom response. Patients with ≤50% improvement on the BFCRS, compared to the score at start, will be eligible for the trial. A total of 42 patients will be randomly assigned to either the sodium oxybate group, after a 2-day lorazepam reduction period, or the continuation of lorazepam. The primary endpoint is response, measured by the BFCRS score change after 4 days of treatment. A ≥50% reduction in BFCRS will define a responder, who will continue allocated treatment for an additional 10 days, with a secondary endpoint at 14 days. Data will be analyzed using intention-to-treat and per-protocol methods, with chi-square and logistic regression tests to compare group response and remission rates. RESULTS: This study was funded by the Dutch Brain Foundation (Hersenstichting) in December 2020. The study protocol was approved by the Amsterdam UMC Ethics Board on May 22, 2023. As of March 2025, the first 4 participants have been included in the cohort, with no trial participants enrolled yet. CONCLUSIONS: If positive, the results of this RCT may pave the way for international catatonia researchers and clinicians to introduce a new pharmacological treatment option for catatonia. Implementation could potentially benefit patients who endure this severe syndrome and present health care professionals with an additional treatment option. TRIAL REGISTRATION: ISRCTN ISRCTN11236443; https://tinyurl.com/4px5s4aa. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/68356.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
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