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Study on Sodium Oxybate for Treating Catatonia in Patients with Depression, Bipolar Disorder, or Psychotic Disorder

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on exploring a new treatment option for patients experiencing catatonia, a condition that can occur in individuals with certain mental health disorders. Catatonia is characterized by symptoms such as lack of movement, unresponsiveness, and sometimes agitation. The study is particularly interested in patients who have catatonia alongside depression, bipolar disorder, or a psychotic disorder. The treatment being tested is called sodium oxybate, which is administered as an oral solution. Sodium oxybate is being compared to the usual care for catatonia, which often involves a medication called lorazepam.

The purpose of this study is to determine if sodium oxybate can be an effective new treatment for catatonia in these patients. Participants in the study will receive either sodium oxybate or the standard treatment, and their response to the treatment will be monitored over a period of time. The study aims to see if there is a significant reduction in catatonia symptoms after four days of treatment.

Throughout the study, participants will be closely observed to assess the effectiveness of sodium oxybate in reducing the symptoms of catatonia. The goal is to find out if this medication can provide a new option for those who do not respond to the usual treatments. This research could potentially lead to better management of catatonia in patients with depression, bipolar disorder, or psychotic disorders.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to meet the inclusion criteria. These include being an adult aged 18 years or older, admitted to an acute psychiatric ward for catatonia treatment, not responding to usual care, and having a diagnosis of unipolar depressive disorder, bipolar disorder, or a psychotic disorder. Catatonia must have been present for no more than eight weeks.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of catatonia symptoms using the Bush-Francis Catatonia Rating Scale (BFCRS). This scale helps in measuring the symptoms and tracking changes over time.

  3. Step 3

    Treatment phase

    The patient receives treatment with sodium oxybate administered orally. The dosage and frequency are determined by the study protocol, aiming to assess the effectiveness of sodium oxybate as a treatment for catatonia.

    The treatment duration is four days, during which the patient's response to the medication is closely monitored.

  4. Step 4

    Response evaluation

    After four days of treatment, the patient's response is evaluated by measuring the change in BFCRS scores. A successful response is defined as a 50% reduction in symptoms.

  5. Step 5

    Follow-up

    Further follow-up assessments may be conducted to monitor the patient's condition and any long-term effects of the treatment.

Who can join the trial?

5 criteria

  • Must be an adult, which means 18 years or older.
  • Must be admitted to an acute psychiatric ward. This is a special hospital area for people with serious mental health issues.
  • Must have **catatonia**, a condition where a person might not move or respond to others, and it hasn't improved with usual care. Usual care includes increasing doses of a medicine called **lorazepam** up to 24 mg over 4 days.
  • Must have a diagnosis according to **DSM-5**, a guide used by doctors to diagnose mental health conditions. The diagnosis should be one of the following: **unipolar depressive disorder** (a type of depression), **bipolar disorder** (a condition with mood swings), or a **psychotic disorder** (a condition that affects how a person thinks, feels, and behaves).
  • Catatonia must have been present for no more than eight weeks.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with catatonia cannot participate. Catatonia is a condition that affects a person's ability to move normally.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate. This means the study is looking for a specific group of people.
  • Patients who are not able to give their own consent to participate cannot join the study. This means they must understand and agree to be part of the trial.
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Investigated drugs

Sodium oxybate is being studied as a potential new treatment for catatonia in patients who have depression, bipolar disorder, or a psychotic disorder. The trial aims to determine if this medication can effectively help manage symptoms of catatonia in these psychiatric conditions.

What is already known about the treatment

Sodium Oxybate – Sodium oxybate is administered orally in liquid form. It is currently being studied as a potential treatment for catatonia in patients with depression, bipolar disorder, or a psychotic disorder. The medication is primarily used to treat narcolepsy with cataplexy, but its use in catatonia is under investigation. Sodium oxybate works by modulating neurotransmitter activity in the brain, particularly affecting gamma-aminobutyric acid (GABA) receptors, which helps to stabilize mood and reduce symptoms of catatonia. It is classified as a central nervous system depressant.

Investigated diseases

Catatonia – Catatonia is a complex neuropsychiatric syndrome characterized by a range of motor, behavioral, and emotional symptoms. Individuals with catatonia may experience periods of immobility or stupor, where they remain in a fixed position for extended periods. They might also exhibit excessive motor activity that appears purposeless and not influenced by external stimuli. Other symptoms can include mutism, negativism, and peculiar posturing. The condition can fluctuate, with episodes of increased symptoms followed by periods of relative calm. Understanding the progression of catatonia is crucial for managing its impact on daily life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517805-10-01Protocol codeNL7793801823Estimated enrolment42 patientsSponsorAmsterdam UMC Stichting

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