MedTrace Logo

Rivastigmine as an Antidote for Clozapine and Other Anticholinergic-Induced CNS Depression and Delirium: A Study of 100 Cases

NCT07545382 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Anticholinergic Delirium
  • Clozapine Poisoning
  • Antipsychotic Toxicity
  • CNS Depression
  • Hypoactive Delirium
  • Tricyclic Antidepressant Poisoning
  • Procyclidine Induced Delirium

Interventions

DRUG

Rivastigmine

Initial Dose: A starting dose of 6 mg is administered either orally or via a Nasogastric Tube (NGT) for patients with impaired swallowing or depressed consciousness. Titration: Additional 6 mg doses are repeated every 2 hours based on clinical need until the resolution of delirium. Alternative Route: Transdermal patches (9.5 mg/24h) are applied in cases where enteral administration is not feasible or based on clinical judgment.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Naima A Sherif, Professor of Forensic Medicine · University of Alexandria

  • Ragaa T Darwish, Professor of Forensic Medicine · University of Alexandria

  • Sahar Y Issa, Assoc Prof Forensic Med · University of Alexandria

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-04-15
Completion
2026-04-15

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545382 on ClinicalTrials.gov