Pharmacological treatment of organic psychosis in critically ill adults

Phase 1

• Conditions: Delirium state in critical ill patients; MedDRA version: 21.0Level: LLTClassification code 10071313Term: Hypoactive deliriumSystem Organ Class: 100000004873; MedDRA version: 21.0Level: LLTClassification code 10012226Term: Delirium, cause unknownSystem Organ Class: 100000004873; MedDRA version: 21.0Level: LLTClassification code 10012220Term: Delirium due to a general medical conditionSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10042275Term: Subacute deliriumSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10013758Term: Drug-induced deliriumSystem Organ Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code 10000702Term: Acute deliriumSystem Organ Class: 100000004873; MedDRA version: 21.0Level: LLTClassification code 10071314Term: Hyperactive deliriumSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-003829-15-IT
• Lead Sponsor: ZEALAND UNIVERSITY HOSPITAL (ERLAND PEDERSEN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-04
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

- Acute admission to the ICU AND
- Age = 18 years AND
- Diagnosed delirium with a validated screening tool as either CAM-ICU or ICDSC
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

Exclusion Criteria

- Contraindications to haloperidol
- Habitual treatment with any antipsychotic medication
- Permanently incompetent (e.g. dementia, mental retardation)
- Delirium assessment non-applicable (coma or language barriers)
- Withdrawal from active therapy or brain death
- Fertile women (women < 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG
- Consent according to national regulations not obtainable
- Patients under coercive measures by regulatory authorities
- Patients with alcohol-induced delirium (delirium tremens)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified