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IRCT20201101049214N1 IRCT 2021-01-27 Tehran University of Medical Sciences effect of modified-release methylphenidate in sleep Comparison of sleep disorders in adult Attention deficit hyperactivity disorder patients treated with immediate-release methylphenidate and modified-release methylphenidate 2020-11-21 anticipated 30 Complete https://irct.ir/trial/52129 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Random Generator using results from random number generation software such as "Toolbox" application. 4 Condition 1: Attention deficit hyperactivity disorder. Condition 2: sleep disorders. Intervention 1: Intervention group 1: Intervention group 1: For 4 weeks, they will be treated with methylphenidate with rapid release made by Pursina company and then for 1 week without drug and then treated with continuous release drug form made by Sandoz company. Intervention 2: Intervention group 2: They will be treated for 4 weeks with continuous release methylphenidate made by Sandoz company and then for 1 week without medicine and then treated with a quick release drug form made by Pursina company. Yes - There is a plan to make this available What will be shared: Changes in people's sleep scores Change sleeping and waking habits When: After publishing the article To whom: Researchers in scientific and academic centers Conditions: At the request of reputable person for scientific development of the topic Coded and raw data Where to obtain: masoudesfahani007@yahoo.com How to obtain: Request in the form of a mail with the sender's details and also the reason for the need for the required data If agree, as soon as possible Comments:
public Masoud Esfahani
No. 41, farz mahdi, modares Ave, qazvin
Qazvin Iran (Islamic Republic of) 3413859478 +98 28 3332 8065 masoudsfhn@gmail.com Tehran University of Medical Sciences scientific Masoud Esfahani
No. 41, farz mahdi, modares Ave, qazvin
Qazvin Iran (Islamic Republic of) 3413859478 +98 28 3332 8065 masoudsfhn@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) adult Patients diagnosis attention deficit hyperactivity disorder start treatment with methylphenidate 18 years no limit Both History of taking any stimulant in the past month Drug abuse Taking sleeping pills such as benzodiazepines or zolpidem Major psychiatric disorders such as bipolar disorder, psychotic disorders, autism and major depression Severe hypertension, heart failure, arrhythmia, hyperthyroidism and thyrotoxicosis, myocardial infarction and angina, glaucoma History of tics and Toure syndrome Existence of neurological diseases that accompany sleep disorders such as epilepsy, vascular disorders, history of stroke, movement and Parkinson's disorders, dementia and cognitive disorders Serious side effects of methylphenidate such as seizures Patient dissatisfaction with entering or continuing the study F90 F51 Attention-deficit hyperactivity disorders Sleep disorders not due to a substance or known physiological condition Treatment - Drugs Treatment - Drugs Intervention group 1: Intervention group 1: For 4 weeks, they will be treated with methylphenidate with rapid release made by Pursina company and then for 1 week without drug and then treated with continuous release drug form made by Sandoz company. Intervention group 2: They will be treated for 4 weeks with continuous release methylphenidate made by Sandoz company and then for 1 week without medicine and then treated with a quick release drug form made by Pursina company. . Anxiety, daily activity, duration and quality of sleep at the beginning and end of each period with the Pittsburgh Questionnaire. Timepoint: At the beginning of the study and at 4 and 8 weeks of treatment. Method of measurement: Face-to-face interview with the patient. Epworth Sleepiness Scale. Timepoint: At the beginning of the study and at 4 and 8 weeks of treatment. Method of measurement: Face-to-face interview with the patient. Tehran University of Medical Sciences Approved 2021-01-24 The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences No. 41, Farz Mahdi Alley, Modares Ave qazvin Qazvin Iran (Islamic Republic of)