Clinical trial • Psychiatry
SODIUM OXYBATE for Catatonia
Clinical trial of SODIUM OXYBATE for Catatonia.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Catatonia
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-10-2024
- First CTIS Authorization Date
- 12-11-2024
Trial design
Randomised, lorazepam (comparator arm). dose/schedule not specified for the comparator arm in the application; the inclusion text notes prior usual care with lorazepam increased up to a maximum of 24 mg during 4 days.-controlled trial across 6 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Lorazepam (comparator arm). Dose/schedule not specified for the comparator arm in the application; the inclusion text notes prior usual care with lorazepam increased up to a maximum of 24 mg during 4 days.
- Target Sample Size
- 42
Eligibility
Recruits 42 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed in the trial documents (titles: 'E1 PIF cohortstudie', 'E1 PIF voor naasten', 'E1 PIF'). No further details on assent or special consent procedures are provided in the available data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms are listed in the trial documents (titles: 'E1 PIF cohortstudie', 'E1 PIF voor naasten', 'E1 PIF'). No further details on assent or special consent procedures are provided in the available data.
Inclusion criteria
- {"criterion_text":"- 1. Adult patients (age 18 years and over) 2. Admission to an acute psychiatric ward for the treatment of catatonia, not responding to 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."}
Exclusion criteria
- {"criterion_text":"- Somatic disorder underlying catatonia.\n- Use of anti-psychotic drugs.\n- Known heart failure or renal impairment due to signifcant amounts of sodium in the sodium-oxybate.\n- Known sleep apnea.\n- Use of Gabaergic drugs including gabapentin or pregabalin or clonidine. Or us of valproate.\n- Presence of alcohol use disorder\n- Presence of malignant catatonia or development of catatonia during the study, i.e. those with malignant catatonia will be treated immediately with ECT"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The response rate after four days of treatment in both groups (lorazepam and sodium oxybate) as measured by difference in BFCRS scores. Response is defined as a 50% reduction in symptoms based on the BFCRS","definition_or_measurement_approach":"Measured by difference in BFCRS (Bush-Francis Catatonia Rating Scale) scores after four days of treatment; response defined as a 50% reduction in symptoms based on the BFCRS."}
Recruitment
- Planned Sample Size
- 42
- Recruitment Window Months
- 47
- Consent Approach
- Subject information and informed consent forms are provided (documents titled 'E1 PIF cohortstudie', 'E1 PIF', 'E1 PIF voor naasten'). Participants are adult (18+) psychiatric inpatients, so consent is provided by participants. No details on assent, age-specific documents, or languages available are provided in the available records.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 42
Netherlands
- Earliest CTIS Part Ii Submission Date
- 02-11-2024
- Latest Decision Or Authorization Date
- 12-11-2024
- Processing Time Days
- 10
- Number Of Sites
- 6
- Number Of Participants
- 42
Sites
- Site Name
- Antes
- Department Name
- psychiatry
- Contact Person Name
- Joris van der Vlugt
- Contact Person Email
- j.vandervlugt@anteszorg.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- psychiatry
- Contact Person Name
- Martijn van Noorden
- Contact Person Email
- m.vannoorden@lumc.nl
- Site Name
- GGZ Centraal
- Department Name
- psychiatry
- Contact Person Name
- Sjors Lange
- Contact Person Email
- s.lange@ggzcentraal.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- psychiatry
- Contact Person Name
- Eric van Exel
- Contact Person Email
- e.vexel@amsterdamumc.nl
- Site Name
- Arkin
- Department Name
- psychiatry
- Contact Person Name
- Roberto Doornebal
- Contact Person Email
- r.doornebal-bakker@mentrum.nl
- Site Name
- GGZinGeest
- Department Name
- psychiatry
- Contact Person Name
- Eric van Exel
- Contact Person Email
- e.vanexel@ggzingeest.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- SODIUM OXYBATE
- Active Substance
- SODIUM OXYBATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Dose Levels
- maxDailyDoseAmount: 27 g; maxTotalDoseAmount: 378 g
- Maximum Dose
- 27 g (max daily)
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