Rivastigmine for the Treatment of Hypoactive Anticholinergic Delirium and CNS Depression Associated Mainly With Clozapine Poisoning.
Efficacy of Rivastigmine in the Management of Toxic Anticholinergic Delirium: A Prospective Study at Alexandria Poison Center
Sponsor: Alexandria University
A observational or N/A phase clinical study on Anticholinergic Delirium and Antipsychotic Toxicity, this trial is completed. The trial is conducted by Alexandria University and has accumulated 1 data snapshot since 2025. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.
Study Description(click to expand)This prospective clinical study evaluates the efficacy of rivastigmine in treating the full spectrum of toxic anticholinergic delirium. The study encompasses both hyperactive (agitated) and hypoactive (depressed mental status/CNS depression) presentations, with a specific focus on the hypoactive variant. While anticholinergic toxicity is traditionally associated with agitation, this research highlights its role in causing hypoactive delirium and assesses how rivastigmine facilitates the recovery of consciousness and cognitive function. Participants: The study includes 100 patients (aged ≥18 years) with confirmed or clinically suspected toxic anticholinergic delirium-characterized by confusion, CNS depression, agitation, disorientation, and/or hallucinations-admitted to the Poison Control Center of Alexandria University Main Hospital (AUMH). Clozapine and TCA Focus: A significant majority of the study population (approximately 90%) consists of clozapine toxicity cases, presenting primarily with hypoactive delirium and CNS depression. Furthermore, the study explores the safety and efficacy of rivastigmine in cases of Tricyclic Antidepressant (TCA) toxicity. Although the use of acetylcholinesterase inhibitors in TCA poisoning has traditionally been approached with caution due to cardiotoxicity concerns, this research evaluates the potential of rivastigmine to safely reverse TCA-induced CNS depression without adverse cardiac events, potentially challenging existing clinical conventions. Intervention Protocol: Administration: An initial enteral dose of 6 mg is administered....
This prospective clinical study evaluates the efficacy of rivastigmine in treating the full spectrum of toxic anticholinergic delirium. The study encompasses both hyperactive (agitated) and hypoactive (depressed mental status/CNS depression) presentations, with a specific focus on the hypoactive variant. While anticholinergic toxicity is traditionally associated with agitation, this research highlights its role in causing hypoactive delirium and assesses how rivastigmine facilitates the recovery of consciousness and cognitive function.
Participants:
The study includes 100 patients (aged ≥18 years) with confirmed or clinically suspected toxic anticholinergic delirium-characterized by confusion, CNS depression, agitation, disorientation, and/or hallucinations-admitted to the Poison Control Center of Alexandria University Main Hospital (AUMH).
Clozapine and TCA Focus:
A significant majority of the study population (approximately 90%) consists of clozapine toxicity cases, presenting primarily with hypoactive delirium and CNS depression. Furthermore, the study explores the safety and efficacy of rivastigmine in cases of Tricyclic Antidepressant (TCA) toxicity. Although the use of acetylcholinesterase inhibitors in TCA poisoning has traditionally been approached with caution due to cardiotoxicity concerns, this research evaluates the potential of rivastigmine to safely reverse TCA-induced CNS depression without adverse cardiac events, potentially challenging existing clinical conventions.
Intervention Protocol:
Administration: An initial enteral dose of 6 mg is administered. In patients with a low Glasgow Coma Scale (GCS) score or those unable to tolerate oral intake, the medication is administered via a Nasogastric Tube (NGT) to ensure rapid delivery.
Dosing: Additional 6 mg doses are administered every 2 hours if CNS symptoms persist.
Assessment \& Resolution:
Clinical evaluation includes monitoring awareness, orientation, and the return of consciousness. The Glasgow Coma Scale (GCS) and Richmond Agitation-Sedation Scale (RASS) are utilized to measure consciousness and arousal at baseline, and at 2, 6, and 8 hours post-administration. Resolution is defined as the restoration of normal consciousness and appropriate interaction. The study also monitors the resolution of peripheral antimuscarinic features, such as the normalization of heart rate.
Status Flow
Change History
1 version recordedEligibility Summary
This study aims to evaluate the clinical efficacy of rivastigmine in reversing the full spectrum of toxic anticholinergic delirium, with a specific focus on hypoactive delirium and CNS depression. These presentations were predominantly associated with clozapine toxicity, accounting for 90% of the study population. Additionally, the research investigates the safety and efficacy of rivastigmine in reversing CNS depression caused by Tricyclic Antidepressants (TCAs), challenging traditional concerns regarding the use of cholinesterase inhibitors in such cases. 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.
Contact Information
- Alexandria University
For direct contact, visit the study record on ClinicalTrials.gov .