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Evaluation of the Effectiveness of Pregabalin for Antipsychotic-Induced Restlessness

Evaluation of the effectiveness of Pregabalin in treating acute neuroleptic-induced Akathisia.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250308064978N1
Enrollment
60
Registered
2025-04-17
Start date
2025-04-05
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Acute akathisia induced by antipsychotic drugs. Drug induced akathisia

Interventions

Intervention 1: Intervention group: Pregabalin at a dose of 50 mg every 8 hours for one week. Intervention 2: Control group: The group received a dose of 50 mg of starch every 8 hours for one week.

Sponsors

Sanandaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: All patients hospitalized at Qods Hospital receiving antipsychotic medications are eligible for inclusion in the study.

Exclusion criteria

Exclusion criteria: Patients with renal problems. Pregnant or breastfeeding women. Patients who do not meet the age criteria for the study (under 18 years and over 65 years). Patients with severe atopy requiring immediate intervention. Patients with a history of allergy to pregabalin or similar medications.

Design outcomes

Primary

MeasureTime frame
The study will include patients whose BARS score is greater than 2. The primary outcome could be the effect of pregabalin on reducing the BARS score. Timepoint: After the start of the study, on the first, fourth, and seventh days, the BARS questionnaire is filled out and recorded. On days 4 and 7 of the study, the drugs' side effects are also evaluated and recorded on the pregabalin side effects checklist. Method of measurement: Based on the Barnes Akathisia Rating Scale, this evaluates the severity of akathisia caused by antipsychotic drugs.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoja dadashi

Sanandaj University of Medical Sciences

rojadadashi@gmail.com+98 87 3366 0025

Outcome results

None listed

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