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Cyproheptadine for prevention of delirium in critically ill patients

Comparing cyproheptadine and placebo efficacy in prevention of delirium incidence in patients hospitalized in intensive care unit

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201312203449N13
Enrollment
40
Registered
2014-01-10
Start date
2013-10-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium. Sudden changes in patients’ behavioral and psychological conditions

Interventions

Intervention 1: Cyproheptadine Tab (Amin Pharmaceutical Company, Isfahan, IRAN), 4mg TDS orally from admission time, as daily interval for 7 days. Incidence and severity of patients’ delirium will be
Prevention
Placebo
Cyproheptadine Tab (Amin Pharmaceutical Company, Isfahan, IRAN), 4mg TDS orally from admission time, as daily interval for 7 days. Incidence and severity of patients’ delirium will be assesses as dail
Placebo Tab (Amin Pharmaceutical Company, Isfahan, IRAN), 4mg TDS orally from admission time, as daily interval for 7 days. Incidence and severity of patients’ delirium will be assesses as daily int

Sponsors

Vice Chancellor for Research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Non-cardiac surgical patients who are admitted to ICU and are hospitalized in Intensive Care Unit (ICU) for at-least 7 days. Exclusion Criteria: Patients with history of neurological diseases, psychiatric disorders, cyproheptadine hypersensitivity, active GI bleeding, glaucoma, urinary retention and arrhythmia will be excluded from the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Incidence of Delirium. Timepoint: At ICU admission and then daily for 7 days. Method of measurement: CAM-ICU Questionnaire.

Secondary

MeasureTime frame
Severity of Delirium. Timepoint: At ICU admission and then daily for 7 days. Method of measurement: CAM-ICU Questionnaire.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026