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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
EU CTIS ID: 2024-517805-10-01
What this study is testing
Our goal is to investigate whether sodium oxybate can be used as a new treatment for psychiatric patients with catatonia.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.