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IRCT20230910059396N1 IRCT 2023-11-04 Islamic Azad University evaluation of lisedexamfetamine dimesylate in tratment of binge eating disorder alone and in combination with topiramte in edults Comprehensive evaluation of lisedexamfetamine dimesylate in tratment of binge eating disorder alone and in combination with topiramte in 18_55 year_old edults 2023-09-16 anticipated 90 Complete https://irct.ir/trial/72533 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48(lisedexamfetamine dimesylate alone groupA) and 45 (lisedexamfetamine dimesylate in combination with topiramate groupB ) using the permuted block randomization method. This is a individual randomization which is done using random allocation software, and a permutation block design was used, where the groups are coded as A, B. Block randomization method with blocks of four is one of the most widely used methods. Therefore, first we call the groups A, B We consider 4 different permutations of these 2 letters The 4 permutations of the two letters A and B are: AABB, ABAB, ABBA, BBAA, BABA, BAAB Each of these is a block of size 4, which includes 2 test group people and 2 control people, we determine randomly by tossing a coin that A, B Which one is the experiment and which one is the control. For allocation concealmen ,the letter A (indicator of intervention group 1 and receiving LDX ) or B (indicator of intervention group 2 and receiving LDX and TPM) are mentioned in the patient's prescription and then the patient is referred for delivery of drugs. 3 Binge eating disorder. Intervention 1: Intervention group: Patients received LDX (n=48) LDX (produced by tekaje pharmaceutical company) was titrated from 30 mg/day to a maximum of 50mg/day for 12weeks. Assessement is done at first and then twelve weeks after receiving the treatment. Intervention 2: Intervention group: 45 patients in the second group received LDX (produced by Tekaje pharmaceutical company)as the same 30 mg/day to a maximum of 50mg/day plus TPM (produced by sobhan pharmaceutical company)with starting dose of 25 mg/day and if tolerated, followed by max dose of 150 mg/day every night for 12weeks.Assessement is done at first and then twelve weeks after receiving the treatment. Yes - There is a plan to make this available What will be shared: According to Declaration of Helsinki with ethical code IR.IAU.KAU.REC.1400.177 due to principle of confidentiality When: Accessrability 6month after release To whom: Scientic and academic researchers Conditions: according to Declaration of Helsinki with ethical code IR.IAU.KAU.REC.1400.177 and with respecting to priciple of confidentiality for scientic researchers,data usage is permitted Where to obtain: 1. Refer to or correspond with the research unit of Kazeroon Islamic Azad University of Kazeroon with postal code of 7319866451 2.or with following adress mail ,Dr_mahsataghavi@yahoo.com How to obtain: Requests will be reviewed by the research unit of Islamic Azad University and the scientific officer of the research within a maximum period of twenty days, and if the necessary conditions are met, the data file will be provided to the requesters. Comments:
public Mahsa taghavi
Psychiatric clinic of Dr Mahsa Taghavi,second floor, Ahoora building, Maaliabad St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7187731139 +98 71 3634 1771 Dr_mahsataghavi@yahoo.com Islamic Azad University scientific Mahsa taghavi
Psychiatric clinic of Dr Mahsa Taghavi,second floor, Ahoora building, Maaliabad St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7187731139 +98 71 3634 1771 Dr_mahsataghavi@yahoo.com Islamic Azad University Iran (Islamic Republic of) Participants aged 18-55 years old meeting the diagnostic criteria for BED according to DSM-5 18 years 55 years Both Posing other major psychiatric disorders assessed by psychiatris (anxiety ,depression,..) Posing physical disease like cardiovascular diseases, thyroid disturbances or gastrointestinal diseases known sensitivity to LDX or TPM. F50-81 Binge eating disorder Treatment - Drugs Treatment - Drugs Intervention group: Patients received LDX (n=48) LDX (produced by tekaje pharmaceutical company) was titrated from 30 mg/day to a maximum of 50mg/day for 12weeks. Assessement is done at first and then twelve weeks after receiving the treatment Intervention group: 45 patients in the second group received LDX (produced by Tekaje pharmaceutical company)as the same 30 mg/day to a maximum of 50mg/day plus TPM (produced by sobhan pharmaceutical company)with starting dose of 25 mg/day and if tolerated, followed by max dose of 150 mg/day every night for 12weeks.Assessement is done at first and then twelve weeks after receiving the treatment. Binge eating score. Timepoint: At first and 3months after. Method of measurement: Bing eating scale of gormally. Body mass index. Timepoint: First qnd 3months after treatment. Method of measurement: Meter and wieght. Islamic Azad University Approved 2022-01-16 Ethics comittee of kazeroon azad university Alley 15,khoramshahr st,kazeroon,iran Kazeroon Fars Iran (Islamic Republic of)