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Comparing risperidone and aripiprazole in ADHD

Comparing response to risperidone and aripiprazol in preschool children with disruptive behavior disorders and ADHD: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014041211983N2
Enrollment
40
Registered
2014-06-29
Start date
2012-03-20
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

ADHD. Disturbance of activity and attention

Interventions

Intervention 1: In the first group oral risperidone with the dose of 0.25 mg once daily is started and and increased by 0.25 mg weekly up to 2 mg per day. Intervention 2: In the second group aripipraz
Treatment - Drugs
In the first group oral risperidone with the dose of 0.25 mg once daily is started and and increased by 0.25 mg weekly up to 2 mg per day.
In the second group aripiprazole is started with the dose of 1.25 mg and increased by 1.25 mg weekly up to 10 mg.

Sponsors

Shahrekord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:age of 3 to 6 years; affected with disruptive behavior disorders and ADHD based on DSM-IV criteria. Exclusion criteria : mental retardation or other developmental disorders such as autism; chronic physical or neurologic diseases; treatment with other psychotropic medications; development of severe and untolerable medication side effects .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of ADHD and ODD symptoms. Timepoint: weeks 0, 2 , 4, and 8. Method of measurement: Short and Revised version of Conners Rating Scale parent form.;Rate of improvement. Timepoint: weeks 2, 4 and 8. Method of measurement: CGI-I scale.

Secondary

MeasureTime frame
Drug side effects. Timepoint: weeks 2, 4 and 8. Method of measurement: checklist.;Level of prolactine and fasting blood sugar. Timepoint: weeks 0 and 8. Method of measurement: lab data.;Body weight. Timepoint: weeks 0 and 8. Method of measurement: weight measurement.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Safavi

Shahrekord University of Medical Sciences

safavi_p@yahoo.com+98 38 1224 1900

Outcome results

None listed

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