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CompletedNCT05793632Updated Jul 10, 2023

Quetiapine in Prevention of Delirium

A Phase 2 interventional study of Quetiapine in Delirium, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Ain Shams University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The aim is to study the effectiveness of Quetiapine in preventing delirium in the elderly patients with multiple risks for delirium.

02

Conditions studied

  • Delirium

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03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 90 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with anemia
  • Sedated patients
  • Hypotensive patients
  • Immobilized patients
  • Patients with visual or auditory impairment

Exclusion criteria

Exclusion Criteria:

  • Patients or guardians refuse to participate
  • Patients diagnosed with delirium
  • Contraindication for delirium
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Quetiapine

    The patients with multiple risks for delirium will receive 25 mg/day PO

    Drug: Quetiapine

  • No intervention
    Non pharmacological preventive bundle

    The patients will only be monitored with application of delirium preventive bundle without pharmacological agent

Interventions

  • DrugQuetiapine

    The patients will be randomly divided into two equal groups group Q and group C. Randomization will be done by computer-generated number lists and using opaque sealed envelopes.

06

What researchers measure

Primary outcomes

  1. Quetiapine in preventing delirium

    The presence of delirium will be monitored among the patients in the two groups using ICU-Confusion Assessment Method 7 score for delirium where a score of (0-2 = no delirium, 3-5 = mild to moderate delirium and a score \>5 = severe delirium)

    Time frame: 2 months

07

Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05793632
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Mar 31, 2023
Start date
Mar 1, 2023
Primary completion
Apr 1, 2023
Completion
Apr 15, 2023
Last update
Jul 10, 2023

Study contacts

Walid Kamel
principal investigator · Faculty of medicine, Ain Shams University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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