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IRCT20221018056238N1 IRCT 2022-11-21 Tehran University of Medical Sciences Comparison of lisdexamphetamine and and methylphenidate in adult ADHD Evaluation of efficacy of treatment with lisdexamphetamine (vyas) in comparison with extended release methylphenidate (sandoz) on improving the quality of life and executive function of adults with attention deficit hyperactivity disorder : an open-lable randomized clinical trial 2022-10-30 anticipated 56 Complete https://irct.ir/trial/66514 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is based on simple randomization method. Foremost, it is agreed that odd numbers will be given to intervention group A (Dex amphetamine treatment) and even numbers will be given to intervention group B (Methylphenidate treatment). Then, according to the number of the studied sample, random numbers or relevant numbers are extracted from the table, each number is written on a card and placed in an envelope, the envelopes are sealed, and the patient's number is written on each envelope. The first patient who is enrolled in the study will be given the envelope number 1, patient number 2, envelope number 2 and so on, this will continue until the end of the study sampling. In order to maintain randomization, the person who prepares the envelopes is different from the main researcher who registers the patients and provides the envelopes to the patients. 2-3 ADULT ADHD. Intervention 1: The first group that receives Lisdexamfetamine (Vyas) for the treatment of ADHD, which will be continued for 8 weeks for each patient. The low dose of drug will start based on the interview and the patient's condition, and the dose will gradually increase according to the patient's symptoms and drug side effects. The optimal dose is 50 mg daily. Intervention 2: The second group that receives sustained release Methylphenidate (Sandoz) for the treatment of ADHD, which will be continued for 8 weeks for each patient. The low dose of drug will start based on the interview and the patient's condition, and the dose will gradually increase according to the patient's symptoms and drug side effects. The optimal dose is 54 mg daily. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The use in other scientific researches is unimpeded by observing the publication rules and mentioning the source Where to obtain: Application by email to the clinical trial registrar How to obtain: After making sure that the data will be clearly used in other scientific researches with reference to the source, it will be delivered to the researcher Comments:
public Azin Aivazziaei
Roozbeh hospital south Karegar Ave.
Tehran Iran (Islamic Republic of) 133715914 +98 21 5541 9151 a-aziaei@razi.tums.ac.ir Tehran University of Medical Sciences scientific Azin Aivazziaei
Roozbeh hospital south Karegar Ave.
Tehran Iran (Islamic Republic of) 133715914 +98 21 5541 9151 a-aziaei@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age more than 16 years Diagnosis of adult attention deficit hyperactive disorder based on DSM-5 Diagnosis of adult attention deficit hyperactive disorder based on DIVA-5 16 years no limit Both Alcohol and other substance us History of Bipolar or psychotic disorders Other psychiatric disorders such as MDD or Autism spectrum disorder Pregnancy or Lactation hypersensitivity to drugs used in this study Neurologic disorders or severe Hepatic or Renal disease BMI less than 18 Dependency to drugs ex. Benzodiazepines MDMA and other substances History of not responding to stimulants Use of any other drug with effects on CNS F90 Attention-deficit hyperactivity disorders Treatment - Drugs Treatment - Drugs The first group that receives Lisdexamfetamine (Vyas) for the treatment of ADHD, which will be continued for 8 weeks for each patient. The low dose of drug will start based on the interview and the patient's condition, and the dose will gradually increase according to the patient's symptoms and drug side effects. The optimal dose is 50 mg daily. The second group that receives sustained release Methylphenidate (Sandoz) for the treatment of ADHD, which will be continued for 8 weeks for each patient. The low dose of drug will start based on the interview and the patient's condition, and the dose will gradually increase according to the patient's symptoms and drug side effects. The optimal dose is 54 mg daily. Primary outcome measure includes changes in scores of BDEFS and WHOQOL scores from the beginning to the end of study. Timepoint: before intervention then 2,4,8 weeks after intervention. Method of measurement: Questioner of Barkley deficits in executive functioning scale for adults , WHO Questioner of quality of life , Clinical global impression GCI Questioner. Tehran University of Medical Sciences Approved 2022-08-13 Ethics committee of medical faculty of university of Tehran Faculty of medicine , Tehran university of medical science , poursina Ave. qods Ave. enghelab Ave Tehran Tehran Iran (Islamic Republic of)