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Completed

NCT Number: NCT05830981

Valproic Acid Use in Patients With Neurological Disorders

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.

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Key information

Conditions

Neurological Disorders Nervous System Diseases

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This quasi-experimental pretest-posttest design study was conducted at the outpatient's pharmacy of Neurology department at tertiary care hospital. After identifying problems with use and completing a follow-up, 3 months of educational intervention (Lectures) among professionals was given. As this study is observational informed consent from all subjects was waived. The subjects were enrolled on the basis of inclusion and exclusion criteria. Patients receiving at least 7 days of Valproic acid, between 10-70 years old, both sexes, were included in the study figure 1. 600 Prescriptions were reviewed between January of 2015 to December of 2017 for patients who were suffering from any psychotic illness and were on psychiatric medications. Then pharmacist educational intervention started and followed up for three months then prescriptions re-evaluted.

Inclusion/ exclusion criteria: The study population was limited to those who were continuously eligible for the outpatient pharmacy refilling thier medications 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. A designed and structured form was used to collect the required information. Data then collected on Microsoft Excel sheet, which included patients' initial therapeutic indications, concomitant use of oral medications, significant adverse drug effects and any drug -drug interaction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients who not use valproate.

Treatment and study plan

Educational Intervention

Other

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

Other names: Educational &counselling sessions

Primary outcomes

  1. Valproate dose (Number)

    Time frame: 3 month

    Right dose

  2. Number of drugs (Number)

    Time frame: 3 Months

    Number of drugs included in the prescriptions analyzed

  3. Medication errors (Number)

    Time frame: 3 Months

    Medication errors regarding frequency or dose of Sodium valproate

  4. Adherence (Number)

    Time frame: 3 Months

    Adherence to medication regimens

  5. Tolerability (Number)

    Time frame: 3 Months

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

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Mansoura University

Registry information

Official study title

Valproic Acid Use Evaluation in Patients With Neurological Disorders: a Retrospective and Prospective Analysis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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