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The Comparison of Aripiprazole versus Risperidone in Attention Deficit Hyperactivity Disorder

The Comparison of Aripiprazole versus Risperidone in Attention Disorder Hyperactivity Disorder in Children Under Six Years old age

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013050413215N1
Enrollment
40
Registered
2013-07-31
Start date
2012-02-29
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

Attention Deficit Hyperactivity Disorder. Hyperkinetic disorders

Interventions

Intervention 1: intervention group: The starting dosage of Aripiprazole is 1.25 mg daily and it will increase 1.25 mg per day every other week depends on the child response. At the same time, they wi
Placebo
Treatment - Drugs
intervention group: The starting dosage of Aripiprazole is 1.25 mg daily and it will increase 1.25 mg per day every other week depends on the child response. At the same time, they will receive place
Control group: The starting dosage of Risperidone is 0.25 mg daily and it will increase 0.25 mg per day every other week depends on the child response. At the same time, they will receive placebo of A

Sponsors

Vice Chancellor for Research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Children from age three to age six with Attention Deficit Hyperactivity Disorder Exclusion Criteria: co-morbidity with Bipolar Disorder; Psychotic Disorder; Mental Retardation;Autistic Disorder;Developmental Delay Disorder; Epilepsy; Any unstable physical conditions that preclude the use of oral medication or continuing treatment process;taking any psychotropic medication in two weeks prior to study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Attention Deficit Hyperactivity scores. Timepoint: two weeks, four weeks, eight weeks and twelve weeks after intervention. Method of measurement: ADHD-RS, C-GAS, CRSP.

Secondary

MeasureTime frame
Medication side effects. Timepoint: Second week. Four weeks, eight weeks, twelve weeks after the intervention. Method of measurement: Side Effect Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Arash Danesh

Behavioral Sciences Research, Shahid Beheshti University of Medical Sciences

khalildanesh@yahoo.com+98 21 7755 1023

Outcome results

None listed

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