Evaluation of risperidone and buspirone in treatment of problem behaviors in children with pku

Evaluaqtion and comparison of therapeutic effects of risperidone and buspirone in treating problem behaviours in children with phenylketonuria

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013011412131N1

Enrollment

Registered

2013-05-06

Start date

2012-04-17

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

phenylketonuria. Disorders of aromatic amino-acid metabolism

Interventions

Intervention 1: Control group includes 13 child with pku between ages 2 to 16 yrs-old that recieve risperidone with gradually increasing doses up to1.5 mg ( and over 30-kg weight with 3 mg) per day fo

Treatment - Drugs

Control group includes 13 child with pku between ages 2 to 16 yrs-old that recieve risperidone with gradually increasing doses up to1.5 mg ( and over 30-kg weight with 3 mg) per day for 8 weeks.

Intervention group include 13 child with phenylketonuria between 2 to 16 yrs -old that recieve buspirone with dose of 2.5mg up to7.5 mg (over 30-kg weight up to 15mg) per day for 8weeks.

Eligibility

Sex/Gender

All

Age

2 Years to 16 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: known case of PKU aged 2 to 16 yrs-old that pediatric psychiatrist comment drug therapy for problem behavior and parents documented consent form. Exclusion criteria: serious drug side effects; need to another psychotropic drug; known hypersensitivity to risperidone and buspirone and no clinical benefit of risperidone and buspirone in the past.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Compliant/calm. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Conduct problem. Timepoint: 2 month. Method of measurement: NISONGER child behavior rating form.;Insecure/Anxious. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Overly sensitive. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Hyperactive. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Self-injury/stereotypic. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Self-isolated/Ritualistic. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Adaptive/social. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.	—

Measure

Time frame

Compliant/calm. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Conduct problem. Timepoint: 2 month. Method of measurement: NISONGER child behavior rating form.;Insecure/Anxious. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Overly sensitive. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Hyperactive. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Self-injury/stereotypic. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Self-isolated/Ritualistic. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.;Adaptive/social. Timepoint: 2 month. Method of measurement: NISONGER child behaviour rating form.

—

Secondary

Measure	Time frame
Clinical global improvement rate. Timepoint: 2 and 4 months. Method of measurement: Clinical global improvement form.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Abdi Ghajarpour

Hamedan University of Medical Sciences

A.ghajarpour@umsha.ac.ir+98 81 1835 0107

Outcome results

None listed

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