Attention-Deficit/Hyperactivity Disorder (ADHD). Attention-deficit hyperactivity disorders
Conditions
Interventions
Intervention 1: Intervention group: Group 1: Receiving risperidone, starting at an initial dose of 0.5 mg daily, titrated up to a maximum of 2 mg per day based on patient tolerance. Intervention 2: In
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: Children aged 3 to 6 years at the time of enrollment A confirmed diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) based on DSM-5 criteria and verified by a specialist physician Written informed consent obtained from parents or legal guardians No concurrent use of psychotropic medications affecting ADHD symptoms at baseline Clinically stable condition with no need for emergency intervention No known history of hypersensitivity or intolerance to risperidone or quetiapine Parents’ ability and willingness to comply with study visits, follow-ups, and completion of assessment questionnaires Acceptable baseline clinical and laboratory evaluations, including:Electrocardiogram (ECG)Fasting blood sugar (FBS)Liver function tests (LFTs)Lipid profile Absence of severe medical or psychiatric comorbidities that, in the investigator’s judgment, could interfere with study outcomes
Exclusion criteria
Exclusion criteria: Presence of any significant medical or neurological disorders, including known cardiovascular diseases, epilepsy, metabolic disorders, or major neurological conditions Clinically significant abnormalities on baseline electrocardiography (ECG) Known hypersensitivity or allergic reaction to risperidone or quetiapine Concurrent use of psychotropic medications or drugs with potential interactions with risperidone or quetiapine Diagnosis of severe psychiatric disorders other than ADHD, including severe autism spectrum disorder, bipolar disorder, schizophrenia, or major depressive disorder Presence of severe developmental delay or significant intellectual disability. Clinically significant abnormal findings in baseline laboratory tests, including lipid profile, liver function tests (LFT), or fasting blood sugar (FBS). Lack of written informed consent from parents or legal guardians. Poor parental cooperation or anticipated non-adherence to follow-up visits and study procedures. Recent prior use of risperidone or quetiapine before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the severity of attention-deficit/hyperactivity disorder symptoms after pharmacological intervention based on the ADHD Rating Scale and Conners’ Parent Rating Scale (CPRS-48), and improvement in overall child functioning based on the Children’s Global Assessment Scale (CGAS). Timepoint: : baseline, and at weeks 2, 6, and 8 after initiation of treatment. Method of measurement: Effectiveness variables are assessed using standardized and validated questionnaires, including the ADHD Rating Scale, Conners’ Parent Rating Scale (CPRS-48), Child Behavior Checklist (CBCL), and Children’s Global Assessment Scale (CGAS). These questionnaires are completed in the form of interviews with parents and, in some cases, with teachers. Safety variables and drug side effects are monitored by conducting regular clinical examinations, measuring growth indices (height, weight, and body mass index), reviewing the results of paraclinical tests (fasting blood sugar, liver function, and lipid profile), and recording electrocardiograms. Adverse effects are also reported and recorded during weekly visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Outcomes:Change in the severity of attention-deficit/hyperactivity disorder symptoms after pharmacological intervention, based on scores obtained from the ADHD Rating Scale and the Conners’ Parent Rating Scale (CPRS-48). Timepoint: Study outcomes will be assessed at four time points: baseline, and at weeks 2, 6, and 8 after initiation of treatment. Method of measurement: Efficacy variables are assessed using standardized and validated questionnaires, including the ADHD Rating Scale, Conners’ Parent Rating Scale (CPRS-48), Child Behavior Checklist (CBCL), and Children’s Global Assessment Scale (CGAS). These questionnaires are completed through interviews with parents and, in some cases, with teachers.;Improvement in overall child functioning based on the Children’s Global Assessment Scale (CGAS). Timepoint: Study outcomes will be assessed at four time points: baseline, and at weeks 2, 6, and 8 after initiation of treatment. Method of measurement: .Safety variables and drug-related adverse effects are monitored through regular clinical examinations, measurement of growth indices (height, weight, and body mass index), assessment of paraclinical laboratory tests (fasting blood glucose, liver function tests, and lipid profile), and electrocardiography. Adverse events are also reported and recorded during weekly follow-up visits. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNazanin Darvishi
Ahvaz University of Medical Sciences
Outcome results
None listed