]>
IRCT20111207008317N3 IRCT 2026-10-13 Ahvaz University of Medical Sciences Effect of adjunctive piracetam on adhdh children Evaluation of the Efficacy of Piracetam as an Adjunct to Methylphenidate in the Treatment of Symptoms of Attention-Deficit/Hyperactivity Disorder in Children: A Randomized Double-Blind Clinical Trial 2026-09-23 anticipated 48 Recruiting https://irct.ir/trial/92014 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be randomly assigned to the intervention and control groups in a 1:1 allocation ratio using block randomization with variable block sizes of 4 and 6 to maintain balance between the groups throughout the study while minimizing the predictability of treatment allocation. The individual participant is the unit of randomization. Each eligible child will be independently assigned to one of the two study groups. Stratified randomization will not be used in this study. The randomization sequence will be generated using R software and randomizer package which is develped to help randomization in clinical trials, and this will be generated by an independent researcher who is not involved in participant recruitment, treatment administration, or outcome assessment. The allocation sequence will be kept in sequentially numbered, opaque, sealed envelopes (SNOSE). The allocation sequence will be generated using a computer-generated random number algorithm based on permuted block randomization with variable block sizes of 4 and 6 and a 1:1 allocation ratio. The sequence will remain concealed until the time of participant assignment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE) containing the treatment assignments. After confirming eligibility and obtaining written informed consent, the next envelope in sequence will be opened by a designated individual responsible for dispensing the study medication. Investigators, participants, parents or legal guardians, treating physicians, and outcome assessors will remain blinded to treatment allocation throughout the study, Blinding description: To maintain blinding, piracetam and placebo will be identical in appearance, color, size, packaging, and labeling, and will be identified only by study codes. Participants and their parents/legal guardians will be blinded to the treatment allocation. The treating child and adolescent psychiatrist and the principal investigator, who are responsible for clinical evaluation and patient follow-up, will remain blinded to group assignment throughout the study. Outcome assessors and data collectors will also be blinded to treatment allocation. The statistical analyst will analyze the data using coded treatment groups (e.g., Group A and Group B) and will remain blinded to the treatment assignments until completion of the primary statistical analysis. Only the independent researcher responsible for generating the randomization sequence and preparing/dispensing the coded study medications will have access to the allocation codes. This individual will have no role in participant recruitment, clinical assessment, outcome evaluation, or data analysis. The allocation codes will remain confidential until completion of data collection and the primary statistical analysis. Emergency unblinding will be permitted only when knowledge of the assigned treatment is essential for the clinical management and safety of a participant. 3 attention deficit hyperactivity disorder (ADHD). Intervention 1: Intervention group:Participants will receive 33% piracetam syrup at a dose of 60 mg/kg/day for six weeks as an adjunct to methylphenidate treatment. The piracetam syrup will be dispensed in containers identical to those used for the placebo and will be indistinguishable to both the investigator and participants. Intervention 2: Control group:Participants will receive placebo as an adjunct to methylphenidate treatment daily for six weeks. The placebo will be identical to the piracetam syrup in appearance, color, odor, viscosity, weight, container, and packaging, and will be prepared by the School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying individuals. When: Access period begins 2 months after publication of results. To whom: Researchers employed at academic and scientific institutions Conditions: Research purposes Where to obtain: ali.vz.ali@gmail.com +989213659375 Ali Vaziri Esfarjani How to obtain: Coordination with the university and relevant faculty must be carried out first Comments:
public Ashraf tashakori
ahvaz-shahr daneshgahi
Ahvaz Iran (Islamic Republic of) 1579461357 +98 61 1374 3038 tashakori-a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Ashraf Tashakori
ahvaz -shahr daneshgahi
Ahvaz Iran (Islamic Republic of) 1579461357 +98 61 1374 3038 tashakori-a@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Children referred to the Child and Adolescent Psychiatry Subspecialty Clinic of Golestan Hospital, Ahvaz. A diagnosis of ADHD according to the DSM-5, established based on the independent clinical judgment of two child and adolescent psychiatrists. No use of medication for the treatment of ADHD during the preceding two weeks. Written informed consent obtained from the parents or legal guardians Absence of any serious medical illness. 7 years 12 years Both Presence of any major psychiatric disorder, such as psychotic disorders, mood disorders, or other major psychiatric conditions. Children with metabolic disorders or chronic underlying medical diseases. Children with any neurological disorder or severe developmental delay. Presence of an acute medical illness at the time of study enrollment. History of substance abuse. Use of any medication for the treatment of ADHD within the two weeks prior to the initiation of the intervention. Intolerance, hypersensitivity, or severe adverse effects related to methylphenidate or piracetam that could compromise participant safety. Presence of severe learning disorders that could interfere with the assessment of ADHD symptoms. Inability to comply with study procedures or withdrawal from the study for any reason during the study period. Refusal of the parents or legal guardians to provide consent for participation in the study. F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Treatment - Drugs Placebo Intervention group:Participants will receive 33% piracetam syrup at a dose of 60 mg/kg/day for six weeks as an adjunct to methylphenidate treatment. The piracetam syrup will be dispensed in containers identical to those used for the placebo and will be indistinguishable to both the investigator and participants. Control group:Participants will receive placebo as an adjunct to methylphenidate treatment daily for six weeks. The placebo will be identical to the piracetam syrup in appearance, color, odor, viscosity, weight, container, and packaging, and will be prepared by the School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences. ADHD score on the Conner's Parent Rating Scale-48 (CPRS-48) questionnaire. Timepoint: Before the start of the trial and then weekly until the end of the sixth week. Method of measurement: Conner's Parent Rating Scale-48 (CPRS-48) questionnaire. The child's overall performance score based on the Children's Global Assessment Scale (CGAS) questionnaire. Timepoint: Before the start of the trial and then weekly until the end of the sixth week. Method of measurement: Children's Global Assessment Scale (CGAS) questionnaire. Executive function based on Behavior Rating Inventory of Executive Function (BRIEF-2) questionnaire. Timepoint: Before the start of the trial and then weekly until the end of the sixth week. Method of measurement: Behavior Rating Inventory of Executive Function (BRIEF-2) questionnaire. Heart rate. Timepoint: Before the start of the trial and then weekly until the end of the sixth week. Method of measurement: Pulse Oximeter. Blood pressure. Timepoint: Before the start of the trial and then weekly until the end of the sixth week. Method of measurement: sphygmomanometer. Ahvaz University of Medical Sciences Approved 2026-08-02 Ethics committee of Jondishapour University of Medical Sciences University City, Ahvaz – Vice-Chancellor for Research and Technology Building, Ahvaz Jundishapur University of Medical Sciences and Health Services – Ground Floor Ahvaz Khouzestan Iran (Islamic Republic of)