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Lorazepam

Clinical trials are investigating Lorazepam in different settings, including acute agitation, agitated behavior in dementia, status epilepticus after cardiac arrest, and healthy volunteers. These studies look at how well it works, how it compares with other treatments or placebo, and what outcomes matter most in each group.

Table of Contents

Clinical trials overview

These trials study Lorazepam in different patient groups and one healthy volunteer group.[1][2][3][4] The studies include Phase 1, Phase 3, and Phase 4 research, so they cover early testing, larger treatment studies, and studies in routine care settings.[1][2][3][4]

The trials are interventional, which means participants receive a study treatment or comparison treatment rather than only being observed.[1][2][3][4] Across the studies, Lorazepam is compared with placebo or with other active medicines, depending on the research question.[1][2][3][4]

Acute agitation in emergency psychiatry

One Phase 4 trial studies adults with acute agitation in emergency psychiatry and includes 132 participants.[1] The study compares a single oral dose of Lorazepam with single-dose sublingual dexmedetomidine and buccal midazolam for acute tranquillization, which means rapid calming of severe agitation.[1]

The main outcome is the change in PANSS Excited Component (PEC) score 60 minutes after dosing.[1] PANSS is a symptom scale, and the excited component measures agitation-related symptoms, so this trial is focused on how quickly and how well the treatment reduces agitation.[1]

Agitated behavior in dementia

Another Phase 3 study looks at people with dementia and agitated behavior that did not respond to guideline-recommended interventions.[2] This trial plans to enroll 100 participants and uses an N-of-1 approach, which means treatment effects are studied in a personalized way for each patient over time.[2]

In this study, Lorazepam is one of the psychotropic drugs being tested against placebo, alongside quetiapine and olanzapine.[2] The main outcome is agitation over time measured with the Cohen Mansfield Agitation Inventory (CMAI).[2] CMAI is a questionnaire-style scale used to track how often agitated behaviors happen.[2]

Status epilepticus after cardiac arrest

The TELSTAR-2 trial is a Phase 3 multicenter randomized study in comatose patients after cardiac arrest who have status epilepticus on continuous EEG, and it plans to enroll 150 participants.[3] Continuous EEG means ongoing brain-wave monitoring, and randomized means participants are assigned to treatment groups by chance.[3]

In this trial, Lorazepam is one of several anti-seizure treatments being studied, including propofol, diazepam, esketamine, valproate, levetiracetam, lacosamide, and midazolam.[3] The study asks whether stepwise seizure suppression improves outcome compared with no anti-seizure treatment.[3]

The main outcome is functional recovery at six months after cardiac arrest, measured with the extended Glasgow Outcome Scale (eGOS) by telephone interview.[3] eGOS is a scale that describes how well a person has recovered after a serious brain injury or illness.[3]

Healthy volunteer pharmacodynamic study

One Phase 1 study is in healthy male participants and includes 24 volunteers.[4] This trial compares Lorazepam with placebo and also compares brexanolone with placebo, using transcranial magnetic stimulation, or TMS, to look at central nervous system pharmacodynamic activity.[4]

Pharmacodynamic activity means the effect of a treatment on the body or brain, and TMS uses magnetic pulses to help measure brain and muscle responses.[4] The primary outcome is the change from baseline in TMS motor evoked potential amplitude, which is a measure of the brain’s response in a muscle test.[4]

Main outcomes and what they mean

The trials use different endpoints because they are studying different questions.[1][2][3][4] In agitation studies, the focus is on symptom scores such as PEC and CMAI, which show whether behavior improves after treatment.[1][2]

In the cardiac arrest study, the outcome is long-term recovery, which is more important than short-term seizure control alone.[3] In the healthy volunteer study, the outcome is a laboratory-style brain response measure, which helps researchers compare the biological effect of treatments in a controlled setting.[4]

References

[1] NCT 2023-510201-18-00. https://clinicaltrials.gov/study/2023-510201-18-00

[2] NCT 2024-510601-29-00. https://clinicaltrials.gov/study/2024-510601-29-00

[3] NCT NCT06549426. https://clinicaltrials.gov/study/NCT06549426

[4] NCT 2022-503019-40-00. https://clinicaltrials.gov/study/2022-503019-40-00

Trial ID Phase Condition studied Status Enrollment
2023-510201-18-00 Phase 4 Acute agitation Authorised 132
2024-510601-29-00 Phase 3 Dementia, agitated behaviour Authorised 100
NCT06549426 Phase 3 Cardiac arrest, comatose, status epilepticus Authorised 150
2022-503019-40-00 Phase 1 Healthy volunteers, CNS PD study Completed 24

FAQ

  • What conditions are being studied with Lorazepam? The trials study acute agitation, agitated behavior in dementia, status epilepticus after cardiac arrest, and pharmacodynamic testing in healthy male volunteers.
  • Who can take part in these Lorazepam trials? The target groups include patients with acute agitation, patients with dementia and agitated behavior, comatose cardiac arrest patients with status epilepticus, and healthy male participants.
  • What are the trial phases for Lorazepam? The trials include Phase 1, Phase 3, and Phase 4 studies. This shows Lorazepam is being tested in early research, later treatment studies, and real-world care settings.
  • What are the trials trying to measure? The studies measure outcomes such as agitation scores, functional recovery after cardiac arrest, and brain response tests in healthy volunteers. These outcomes help show whether the treatment is working.
  • Is Lorazepam always being tested alone? No. In some trials, Lorazepam is compared with placebo or other medicines such as quetiapine, olanzapine, midazolam, dexmedetomidine, and several anti-seizure treatments.

Ongoing Clinical Trials on Lorazepam

  • Title: Evaluation of lorazepam, pregabalin, and olanzapine in treating agitated behavior in dementia patients who did not respond to standard treatments

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of anti-seizure drug combination in comatose patients with status epilepticus after cardiac arrest

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium The Netherlands

  • Study on Dexmedetomidine, Midazolam, and Lorazepam for Treating Acute Agitation in Emergency Psychiatry Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study to evaluate the effects of brexanolone and lorazepam on the nervous system in healthy male participants using magnetic brain stimulation

    Not recruiting

    1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Acute agitation: A sudden state of severe restlessness, distress, or aggressive behavior that may need urgent treatment.
  • Agitated behavior: Behavior linked to restlessness, worry, or upset, often seen in people with dementia.
  • Dementia: A condition that affects memory, thinking, and daily function.
  • Status epilepticus: A medical emergency where seizures continue for a long time or happen one after another without recovery.
  • Comatose: In a deep state of unconsciousness, where a person cannot be awakened normally.
  • Cardiac arrest: A sudden stop in the heart’s pumping action.
  • Placebo: A look-alike treatment with no active medicine, used to compare results fairly.
  • Phase 1: An early trial phase that usually checks how a treatment affects the body and helps compare responses.
  • Phase 3: A later trial phase that tests how well a treatment works in larger groups.
  • Phase 4: A trial phase done after a treatment is already in use, often to study how it performs in practice.
  • Primary outcome: The main result a trial is designed to measure.
  • Functional recovery: How well a person is able to recover daily function after a serious illness or event.

References

  1. https://clinicaltrials.gov/study/2023-510201-18-00
  2. https://clinicaltrials.gov/study/2024-510601-29-00
  3. https://clinicaltrials.eu/trial/study-on-anti-seizure-treatment-with-esketamine-lorazepam-and-midazolam-for-comatose-patients-after-cardiac-arrest-with-status-epilepticus/
  4. https://clinicaltrials.gov/study/2022-503019-40-00