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IRCT20090117001556N108 IRCT 2018-04-06 Tehran University of Medical Sciences Tipeptidine as adjuvant therapy in children with ADHD Tipeptidine as adjuvant therapy in children with ADHD: A double blind and randomised trial 2018-04-19 anticipated 50 Complete https://irct.ir/trial/30360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocks ( each block has four cases), Blinding description: The participants, clinicians and outcome evaluators will be blind regarding grouping. 3 Disturbance of activity and attention. Intervention 1: Control group: Ritaline 10 to 30 mg per day and placebo as control group for 8 weeks. Intervention 2: Intervention group: Ritaline 10 to 30 mg per day and tipetidine 30 mg per day as intervention group for 8 weeks. Yes - There is a plan to make this available What will be shared: All data will be distributed through final report When: from 2021 to 2026 To whom: academic researchers Conditions: by E mail Where to obtain: prof Shahin Akhondzadeh How to obtain: s.akhond@sina.tums.ac.ir Comments:
public Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street,
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street
Tehran Iran (Islamic Republic of) 1333715914 +98 912 171 1045 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of ADHD based on DSM-5 Age between 6-17 years old 6 years 17 years Both Intellectual disability Presence of any psychiatric disorders except for ODD Receiving any neuroleptic during the last 6 months Weight less than 13.5 kg History of allergy to Tipeptidine or Ritaline Presence of any neurologic disease and any condition requiring surgery Uncontrolled seizures Systolic blood pressure more than 125 mm Hg; resting pulse rate less than 60/minute or more than 115/minute Severe medical disease Receiving any medication or supplement for treatment ADHD F90.2 Attention-deficit hyperactivity disorder, combined type Placebo Treatment - Drugs Control group: Ritaline 10 to 30 mg per day and placebo as control group for 8 weeks Intervention group: Ritaline 10 to 30 mg per day and tipetidine 30 mg per day as intervention group for 8 weeks Severity of ADHD. Timepoint: Week 0 (before treatment) and Weeks 4 and 8 after treatment. Method of measurement: Teacher and Parent ADHD Rating Scale. Tehran University of Medical Sciences Approved 2019-03-03 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blv tehran Tehran Iran (Islamic Republic of)