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.

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. - Laborit study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54182

Enrollment

Registered

2023-05-22

Start date

2023-09-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

1) Patients with catatonia will receive care as usual: they will be titrated to a dosage of lorazepam up to 24mg daily in 4 days, until response of catatonia symptoms occurs. 2) If no response occur

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
We will use logistic regression, to assess the response rate after 4 days of treatment between groups.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)