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.

Phase 3

Conditions: Katatonie
Catatonia
syndrome associated with psychomotor disturbances
with either a retarded or excited nature
10037176

Registration Number: NL-OMON56950

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 42

Inclusion Criteria

-Patients (age 18-80) with catatonia
-With DSM-5 diagnosis of either unipolar depression, bipolar disorder, or a
psychotic disorder admitted to an acute psychiatric ward.
-No response to usual care, with increasing doses of lorazepam to a maximum of
24 mg during 4 days.
-Presence of catatonia will be assessed using the BFCTRS(15). Catatonia is
considered present with a score of two or higher on the BFCTRS.
-Catatonia is present for a maximum of eight weeks.

Exclusion Criteria

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will use logistic regression, to assess the response rate after 4 days of<br /><br>treatment between groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) To determine remission of catatonia, by comparing remission to either high<br /><br>dose of lorazepam or sodium oxybate, after 10 days of treatment. We will only<br /><br>determine remission in patients who responder after 4 day of treatment with<br /><br>either lorazpam or sodium oxybate..<br /><br>2) To determine which side effects occur if sodium oxybate is administered in<br /><br>patients with catatonia, with an emphasis on oxygen levels, blood pressure,<br /><br>heart rate and vomiting, i.e. with regard to the risk to develop aspiration<br /><br>pneumonia.</p><br>