Sodium oxybate as a potential new treatment for catatonia in patients with depression, bipolar disorder or a psychotic disorder

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 42

Inclusion Criteria

1. Adult patients (age 18 years and over)
2. Admition to an acute psychiatric ward for the treatment of catatonia, not responedingto 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. Not able to take drugs orally, i.e., subjects who actively resist treatment, and are thus not able/or want to take oral sodium oxybate
2. Somatic disorder underlying catatonia
3. Use of anti-psychotic drugs if patients prior to the development of catatonia either had an increase or change in anti-psychotic medication. Patients that have been treated with a stable dose of antipsychotics for a longer period of time should be allowed to be treated further with anti-psychotic medication if the patient’s treating psychiatrist deems this necessary and catatonia is mild, i.e. BFRCS <9
4. Known heart failure or renal impairment due to significant amounts of sodium in the sodium oxybate
5. Known sleep apnoea.
6.1. Use of GABAergic drugs including gabapentin, pregabalin and clonidine
6.2. Use of GHB dehydrogenase inhibitors, including valproate, phenytoin and ethosuximide
6.3. Use of opioids, except tramadol
7. Presence of alcohol use disorder
8. Presence of malignant catatonia (as is indicated by autonomic dysregulation, item 23 of the Bush Francis Catatonia rating scale, scoring 3 combined with moderately severe to severe muscle rigidity, item 11 of the Bush Francis Catatonia rating scale, scoring 2 or higher) or development of malignant catatonia during the study
Patients with malignant catatonia need to receive treatment with ECT as soon as possible since mortality in those with untreated catatonia ranges between 10 and 40%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
1. Remission based on differences in BFCRS score after four and ten days of treatment. Remission is defined as a BFCRS score lower than 3 points or not fulfilling DSM 5 criteria for catatonia, i.e. 2 out of 12 classification criteria for catatonia<br>2. Occurence of side effects in both treatment groups (high dose lorazepam and sodium oxybate) measured using patient records thoroughout<br>3. Prevalence of retarded type catatonia versus excited type catatonia as measured by clinical factors that are scored in the BFCRS after four and ten days of treatment

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