ClinicalTrials.gg
RecruitingNCT04530734PHARMAPREDICATUpdated May 22, 2026

Blood Concentration in Lorazepam and Treatment in Adult Catatonia

An observational study in Catatonia, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Jan 2020; still recruiting 6 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Catatonia

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03

In context

Catatonia

22 studies on the registry are indexed under Catatonia; 10 are open to participants now.

Browse Catatonia studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • catatonia according

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

    Time frame: at 72 hours of treatment with lorazepam

07

Study locations

1 of 1 sites recruiting
  • Hôpital Fontan, CHU lille
    Lille, 59037, France
    Recruiting
    • · Contact0320445962
    • Ali Amad, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2020 (actual). Primary completion is estimated for Jan 2027, 84 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2020
First posted
Aug 28, 2020
StartActual
Jan 1, 2020
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04530734
Responsible party
Sponsor
First posted
Aug 28, 2020
Start date
Jan 1, 2020
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
May 22, 2026

Study contacts

Ali AMAD, MD
Contact
ali.amad@chru-lille.fr
03 20 44 44 60 ext. +33
Ali AMAD, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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