Valproic Acid Use in Patients With Neurological Disorders

NCT05830981 | Completed

• 1 other identifier: valproic acid therapy
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sodium valproate is a well-known anticonvulsant used in the treatment of epilepsy and bipolar disorder, as well as other psychiatric conditions requiring the administration of mood stabilizers. Aim of the present study is to assess sodium valproate usage among patients with neurological disorders. Prescriptions of 600 patients from out-patient pharmacy of neurology department at Mansoura university teaching hospital were analyzed in a retrospective prospective observational study which conducted between January 2015 and December 2017. Data collected include: demographic data, medical history, drug-drug interaction, polypharmacy, medication error, doses and therapeutic duplication. A designed and structured form was used to collect the required information.

Conditions

Neurological Disorders

Keywords

Valproate use

Outcome Measures

Primary Outcomes (5)

• Valproate dose (Number)

  Right dose

  3 month

• Number of drugs (Number)

  Number of drugs included in the prescriptions analyzed

  3 Months

• Medication errors (Number)

  Medication errors regarding frequency or dose of Sodium valproate

  3 Months

• Adherence (Number)

  Adherence to medication regimens

  3 Months

• Tolerability (Number)

  tolerability was assessed through monitoring of ADRs and recorded in the patient's file.

  3 Months

Study Arms (2)

Phase 1

NO INTERVENTION

n=600

Phase 2

ACTIVE COMPARATOR

n=504

Other: Educational intervention

Interventions

Educational intervention OTHER

3 months of educational intervention (Lectures, information bulletin, handbook and hardcopy presentation slides) among professionals and patients.

Also known as: Educational &counselling sessions

Phase 2

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The study population was limited to those who prescribed with valproate and were continuously eligible for the outpatient during the entire study period. Patients were identified through pharmacy drug prescriptions By hospital policy all drugs are prescribed for a maximum period of 3 months. Consequently, all patients presented at least twice during the study period.

You may not qualify if:

• Patients who not use valproate.

Sponsors & Collaborators

• Damanhour University: lead
• Mansoura University: collaborator

Related Publications (4)

• Thakkar KB, Jain MM, Billa G, Joshi A, Khobragade AA. A drug utilization study of psychotropic drugs prescribed in the psychiatry outpatient department of a tertiary care hospital. J Clin Diagn Res. 2013 Dec;7(12):2759-64. doi: 10.7860/JCDR/2013/6760.3885. Epub 2013 Dec 15.

  PMID: 24551631 BACKGROUND

• Bell JS, Whitehead P, Aslani P, McLachlan AJ, Chen TF. Drug-related problems in the community setting: pharmacists' findings and recommendations for people with mental illnesses. Clin Drug Investig. 2006;26(7):415-25. doi: 10.2165/00044011-200626070-00003.

  PMID: 17163274 BACKGROUND

• Nanaumi Y, Yoshitani A, Onda M. Impact of interventions by a community pharmacist on care burden for people with dementia: development and randomized feasibility trial of an intervention protocol. Pilot Feasibility Stud. 2022 Jun 2;8(1):118. doi: 10.1186/s40814-022-01071-7.

  PMID: 35655244 BACKGROUND

• Werida RH, El-Sherif S, Shoshan R, Khedr NF. Evaluation of prescribing patterns of sodium valproate in neurological disease patients: a quasi-experimental pretest-posttest design study. BMC Health Serv Res. 2025 Mar 27;25(1):441. doi: 10.1186/s12913-025-12483-5.

  PMID: 40140829 DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Rehab H Werida, Ass. Prof.

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A quasi-experimental pretest-posttest design study.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: January 1, 2015
• Primary Completion: December 20, 2017
• Study Completion: December 31, 2017
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share