Blood Concentration in Lorazepam and Treatment in Adult Catatonia

NCT04530734 | Recruiting

• 2 other identifiers: 2018_172019-A01208-49
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Catatonia

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

102 patients with catatonia. 70 responder patients, 32 non responder

You may qualify if:

• catatonia according DSM-5

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Fontan, CHU lille

Lille, 59037, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from blood

MeSH Terms

Conditions

Catatonia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Ali AMAD, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali AMAD, MD

CONTACT

03 20 44 44 60; ali.amad@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: August 28, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)