Evaluation of Sodium Oxybate for the Treatment of Catatonia in Patients with Depression, Bipolar Disorder, or Psychotic Disorders: A Randomized Controlled Trial

The primary objective of this study is to evaluate the efficacy of **sodium oxybate** as a novel treatment for patients experiencing **catatonia** associated with depression, bipolar disorder, or a psychotic disorder. This investigation is clinically significant as catatonia is a severe neuropsychiatric syndrome that can complicate the management of these psychiatric conditions, and current treatment options are limited. The study aims to determine whether sodium oxybate can provide a new therapeutic avenue for these patients, potentially improving clinical outcomes and quality of life.

The clinical trial focuses on evaluating the efficacy of sodium oxybate as a potential treatment for psychiatric patients diagnosed with **catatonia**. The study population includes adult participants aged 18 years and older, admitted to an acute psychiatric ward due to catatonia that has not responded to standard care, specifically increasing doses of lorazepam up to 24 mg over four days. The trial encompasses both male and female subjects, with no specific exclusion based on gender. Participants are required to have a DSM-5 classification of either unipolar depressive disorder, bipolar disorder, or a psychotic disorder, with catatonia present for a maximum duration of eight weeks. The trial includes a vulnerable population, indicating a careful consideration of ethical standards in the selection process. However, the sponsor has not provided information regarding the total number of participants involved in the study. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **sodium oxybate** as a potential treatment for **catatonia** in patients with depression, bipolar disorder, or a psychotic disorder. This study is a randomized, controlled trial with a double-blind design to ensure unbiased results. The trial is expected to commence on October 1, 2024, and conclude by September 30, 2028. Participants will be involved in the study for a maximum treatment period of two weeks, with the primary endpoint being the response rate after four days of treatment, measured by a 50% reduction in symptoms using the Bush-Francis Catatonia Rating Scale (BFCRS).

Study visits will follow a structured sequence, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (18 years and over), admission to an acute psychiatric ward, and a DSM-5 classification of the relevant psychiatric disorders. Catatonia must be present for a maximum of eight weeks, and participants must have shown resistance to usual care, specifically lorazepam. Follow-up visits will occur throughout the treatment period to monitor progress and assess the primary endpoint. The end-of-study visit will evaluate the overall response to treatment and collect final data.

Participants are expected to adhere to the study protocol for the entire duration unless specific conditions necessitate early termination. Such conditions include adverse reactions to the treatment, withdrawal of consent, or any significant protocol deviations. The trial aims to provide valuable insights into the potential use of sodium oxybate for treating catatonia, contributing to the broader understanding of therapeutic options for this condition.

The clinical trial involves the administration of **sodium oxybate**, an experimental medication, as a potential treatment for catatonia in patients with depression, bipolar disorder, or a psychotic disorder. Sodium oxybate is provided in the form of an **oral solution**. The active substance, sodium oxybate, is of chemical origin. The medication is administered via the oral route. The dosing regimen allows for a maximum daily dose of 27 grams, with a total maximum dose of 378 grams over the course of the treatment period. The maximum treatment period is set at 2 weeks. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the protocol.

In this study, sodium oxybate is the sole experimental treatment being evaluated. There are no non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, included in the trial design. The trial aims to assess the efficacy and safety of sodium oxybate as a novel therapeutic option for catatonia in the specified patient population. The study protocol includes detailed monitoring of participant compliance with the dosing schedule to ensure accurate assessment of the treatment's effects.

Efficacy in this clinical trial will be assessed by evaluating the response rate after four days of treatment in both the lorazepam and sodium oxybate groups. The primary endpoint is defined as a 50% reduction in symptoms of **catatonia** as measured by the Bush-Francis Catatonia Rating Scale (BFCRS). The BFCRS is a validated tool used to quantify the severity of catatonia symptoms, and the difference in BFCRS scores between the two groups will be analyzed to determine the efficacy of sodium oxybate as a treatment option. The trial aims to establish whether sodium oxybate can serve as a novel treatment for psychiatric patients with catatonia who are resistant to lorazepam. The assessment will be conducted at the four-day mark, providing a clear and measurable endpoint for evaluating the treatment's effectiveness.