Blood Concentration in Lorazepam and Treatment in Adult Catatonia

Catatonia Clinical Trial

— PHARMAPREDICAT  

Official title:

Blood Concentration in Lorazepam and Treatment in Adult Catatonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04530734
• Other study ID #: 2018_17
• Secondary ID: 2019-A01208-49
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: March 2025

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Ali AMAD, MD
• Phone: 03 20 44 44 60
• Email: ali.amad[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Catatonia is a severe form of psychomotor disturbance with a heterogenous presentation. It affects approximately 10% of acute psychiatric inpatients. According to the fifth edition of DSM-5 the diagnosis of catatonia can be made when three or more symptoms from the twelve following are present : catalepsy, waxy flexibility, stupor, agitation, mutism, negativism, posturing, mannerisms, stereotypies, grimacing, echolalia, echopraxia. It can occur in various psychiatric diseases, including mood disorders or schizophrenia, but also in various non-psychiatric disorders [metabolic disturbances, viral infections (including HIV), typhoid fever, heat stroke, and autoimmune disease].

Benzodiazepines, especially LORAZEPAM, are the most common initial treatment, with a remission rate of approximately 70-80 %, regardless of the cause or the clinical manifestations. This first line treatment is titrated gradually according to the therapeutic response over a few days up to 20-25 mg per day. Electroconvulsive therapy (ECT) is initiated on patients with catatonia who do not respond to benzodiazepines.

Interestingly, pharmacogenetic variants can alter the metabolism of lorazepam (e.g., the UGT2B15 * 2 allele slows it down).

The main objective of this study is to assess the link between clinical response to lorazepam, residual plasma concentrations of lorazepam after 72 hours of fixed dosage, and the existence of genetic polymorphisms modifying the metabolism of lorazepam. Our hypothesis is that non-responding patients have lowered blood concentrations of lorazepam associated to a genetic profile of rapid metabolism. Evaluating the predictive factors of the response to treatment would allow early and precise identification of non-responder patients in order to adapt their first-line treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• catatonia according DSM-5

Exclusion Criteria:

• Subject is less than 18 years of age

• Subject is pregnant at the time of the study

• Subject/legal guardian unwilling to participate in the study

Related Conditions & MeSH terms

• Catatonia

Locations

Country	Name	City	State
France	Hôpital Fontan, CHU lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of lorazepam measured after 72 hours of treatment with lorazepam at fixed dose	Compare the residual plasma concentration of lorazepam after 72 hours of taking fixed-dose lorazepam between responder and non-responder patients defined by the persistence of this diagnosis despite a daily dosage of 24 mg of lorazepam for 72 hours	at 72 hours of treatment with lorazepam