Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
42
Countries
1
Sites
6
Catatonia
Our goal is to investigate whether sodium oxybate can be used as a new treatment for psychiatric patients with catatonia.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 12 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517805-10-01
- EudraCT number
- 2021-004049-19
- ISRCTN
- ISRCTN11236443
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
Our goal is to investigate whether sodium oxybate can be used as a new treatment for
psychiatric patients with catatonia.
Conditions and MedDRA coding
Catatonia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10081006 | Bush-Francis catatonia rating scale | 100000004848 |
| 20.0 | PT | 10007776 | Catatonia | 100000004873 |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Data sharing is possible through the Laborit Consortium
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517805-10-00 | 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 Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 1
- Somatic disorder underlying catatonia.-Use of anti-psychotic drugs.-Known heart failure or renal impairment due to signifcant amounts of sodium in the sodium-oxybate.-Known sleep apnea.-Use of Gabaergic drugs including gabapentin or pregabalin or clonidine. Or us of valproate.-Presence of alcohol use disorder-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 and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB14731MIG · Substance
- Active substance
- Sodium Oxybate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 27 g gram(s)
- Max total dose
- 378 g gram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Eric van Exel
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Eric van Exel
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 42 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC Stichting
psychiatry, Meibergdreef 9, 1105 AZ, Amsterdam
Leids Universitair Medisch Centrum (LUMC)
psychiatry, P. O. Box 9600, 2300 RC, Leiden
GGZinGeest
psychiatry, Amstelveenseweg 589, 1081 JC, Amsterdam
GGZ Centraal
psychiatry, Laan van de Heelmeesters 2, Netherlands, Hilversum
Antes
psychiatry, Maasstadweg 96, Netherlands
Arkin
psychiatry, Klaprozenweg 111, 1033 NN, Amsterdam
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-11-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | C1 Laborit | 12 |
| Recruitment arrangements (for publication) | K1 recruitment procedure empty placeholder document | 1 |
| Subject information and informed consent form (for publication) | E1 PIF | 5 |
| Subject information and informed consent form (for publication) | E1 PIF cohortstudie | 5 |
| Subject information and informed consent form (for publication) | E1 PIF voor naasten | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_IMPD_Q Sodium Oxybate SmPC xyrem-epar-product-information_en | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC xyrem-epar-product-information_en | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-21 | Netherlands | Acceptable 2024-11-12
|
2024-11-12 |