Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 21, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07545382). This is a study registration, not published results. Lead sponsor: Alexandria University. Recruitment status: COMPLETED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 100 participants (ACTUAL). Conditions: Anticholinergic Delirium, Clozapine Poisoning, Antipsychotic Toxicity, CNS Depression, Hypoactive Delirium, Tricyclic Antidepressant Poisoning, Procyclidine Induced Delirium. Interventions: DRUG: Rivastigmine. Primary outcome measures: Change in Glasgow Coma Scale (GCS) Score. , Baseline (0 hour), 2 hours post-administration (all patients), 6-8 hours, and 12 hours (transdermal group). For patients receiving additional oral/NGT doses, assessments were repeated 2 hours after each supplemental dose up to 6 hours after resolution.; Change in Richmond Agitation-Sedation Scale (RASS) Score , Baseline, 2h (all), 6-8h & 12h (patch group), and up to 6h post-resolution (both groups). Brief summary: This study aims to evaluate the clinical efficacy and safety of rivastigmine in reversing the full spectrum of anticholinergic delirium including hypoactive delirium which is presented with CNS depression and hyperactive or agitated delirium. The study was conducted on 100 patients at the Poison Control Center of Alexandria University Main Hospital. The primary objective is to assess the effectiveness of rivastigmine in restoring consciousness and improving cognitive function in patients presenting with delirium and depressed mental status using GCS and RASS score.