In short
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.
Key points
- Clinical trials of Lorazepam are being done in several different groups, including people with acute agitation, dementia with agitated behavior, comatose patients after cardiac arrest, and healthy male volunteers. The studies range from Phase 1 to Phase 4, so they include early testing and later clinical research. Some trials compare Lorazepam with placebo or other medicines, while others look at it as part of emergency treatment plans. The main outcomes include agitation scores, brain response measures, and recovery after cardiac arrest. These trials help show how Lorazepam is being studied in both urgent care and research settings.
Clinical trials overview
These trials study Lorazepam in different patient groups and one healthy volunteer group. 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.
The trials are interventional, which means participants receive a study treatment or comparison treatment rather than only being observed. Across the studies, Lorazepam is compared with placebo or with other active medicines, depending on the research question.
Acute agitation in emergency psychiatry
One Phase 4 trial studies adults with acute agitation in emergency psychiatry and includes 132 participants. 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.
The main outcome is the change in PANSS Excited Component (PEC) score 60 minutes after dosing. 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.
Agitated behavior in dementia
Another Phase 3 study looks at people with dementia and agitated behavior that did not respond to guideline-recommended interventions. 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.
In this study, Lorazepam is one of the psychotropic drugs being tested against placebo, alongside quetiapine and olanzapine. The main outcome is agitation over time measured with the Cohen Mansfield Agitation Inventory (CMAI). CMAI is a questionnaire-style scale used to track how often agitated behaviors happen.
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. Continuous EEG means ongoing brain-wave monitoring, and randomized means participants are assigned to treatment groups by chance.
In this trial, Lorazepam is one of several anti-seizure treatments being studied, including propofol, diazepam, esketamine, valproate, levetiracetam, lacosamide, and midazolam. The study asks whether stepwise seizure suppression improves outcome compared with no anti-seizure treatment.
The main outcome is functional recovery at six months after cardiac arrest, measured with the extended Glasgow Outcome Scale (eGOS) by telephone interview. eGOS is a scale that describes how well a person has recovered after a serious brain injury or illness.
Healthy volunteer pharmacodynamic study
One Phase 1 study is in healthy male participants and includes 24 volunteers. 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.
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. 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.
Main outcomes and what they mean
The trials use different endpoints because they are studying different questions. In agitation studies, the focus is on symptom scores such as PEC and CMAI, which show whether behavior improves after treatment.
In the cardiac arrest study, the outcome is long-term recovery, which is more important than short-term seizure control alone. 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.
References
NCT 2023-510201-18-00. https://clinicaltrials.gov/study/2023-510201-18-00
NCT 2024-510601-29-00. https://clinicaltrials.gov/study/2024-510601-29-00
NCT NCT06549426. https://clinicaltrials.gov/study/NCT06549426
NCT 2022-503019-40-00. https://clinicaltrials.gov/study/2022-503019-40-00