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IRCT20200805048313N1 IRCT 2022-02-10 Karaj University of Medical Sciences determination of Empagiflozin effect as an adjunct therapy for treatment of Major depressive disorder determination of Empagiflozin effect as an adjunct therapy for treatment of Major depressive disorder in a double blind placebo control clinical trial by using Hamilton questionnaire 2022-04-19 anticipated 80 Complete https://irct.ir/trial/51645 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using a computerized random number generator, study subjects will be randomized in a 1 : 1 ratio in blocks of four to receive either Empagliflozin or placebo in addition to their standard treatment.in this method the subjects receiving Empagliflozin or placebo will be chosen by the system. In this study randomized allocation of the two intervention groups(drug or placebo) in standard time will be done by permuted balance block technique. the considered blocks of this study will be blocks of four. A series of randomized numbers of 1 to 6 is produced by using "Envelope" application . preparing randomized allocated series of interventional groups and putting them in stapled ,sealed and opaque envelopes with 5 digit serial number ,will be done by a third person who has no role in the study. All envelopes have a 5 digit serial number which will be immediately opened after entry of each volunteer in the study and the patients will be divided into two groups of Drug and Placebo, Blinding description: This study is a double blinded clinical trial .Allocation concealment will be done using sequentially numbered, sealed, opaque, and stapled envelopes. Separate persons are responsible for randomization and allocation, as well as interviewing. The physician who refers the patient, the patients, the resident who administer the drugs and rated the patients, and the statistician will be blinded to allocation. 3 Major depression disorder. Intervention 1: Control group: 40 patients who receive Placebo similar to the main medicine from any aspect (taste, color and shape). they receive placebo( once daily)in addition to their standard MDD treatment( Citalopram 40 mg oral agent ) for 2 months. Intervention 2: Intervention group: 40 patients who receive Empagliflozin (10 mg once daily from Abidi Company) in addition to their MDD standard treatment( Citalopram 40 mg once daily) for 2 months; both as oral agent. Yes - There is a plan to make this available What will be shared: All findings from this trial will be made public. In order to publish it, patients' personal information and their names will not be disclosed, but all scientific information will be made available to the public. When: Public access will be established up to six months after the end of the study. To whom: The public and those interested in scientific information will have access to this trial findings. Conditions: All statistical analysis and classified information will be provided to them. Where to obtain: If requested, please refer to mary.pn96@gmail.com e-mail. How to obtain: The applicant can use the information within 24 hours if the request for the results of our study is announced at the email address mentioned. Comments:
public Dr Atefeh Zandifar
No20 Mersad ave. Sepehr ave. Dadman blvd Tehran Iran
Tehran Iran (Islamic Republic of) 1356646555 +98 21 8897 5154 mary.pn96@gmail.com Karaj University of Medical Sciences scientific Dr Atefeh Zandifar
No20 Mersad ave. Sepehr ave. Dadman blvd Tehran Iran
Tehran Iran (Islamic Republic of) 1356646555 +98 21 8897 5154 mary.pn96@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) patients with MDD based on DSM V criteria while Hamilton score is equal to 22 or more than 22. 18 years 60 years Both Being psychotic Having Other disorders in axis 1 or 2 Using other psychedelic drugs Has taken Anti depressant agents in last month Or ECT in the 2 last months. Hypothyroidism Positive Cardiovascular disease history Pregnancy or Lactation Renal disease Diabetes type 1 Age < 18 or Age>60 years old IQ <70 Medical history of seizure and CNS disorders Using Betablocker agents Using drugs rather than Nicotine and Caffeine Urinary tract infection Mao inhibitors such as Azilect ,Marplan ,Aspirin ,Gabapentin , Pantoprazole ,Omeprazole Pancreatitis Hypotension F32.2 Major depressive disorder, single episode, severe without psychotic features Treatment - Drugs Treatment - Drugs Control group: 40 patients who receive Placebo similar to the main medicine from any aspect (taste, color and shape). they receive placebo( once daily)in addition to their standard MDD treatment( Citalopram 40 mg oral agent ) for 2 months. Intervention group: 40 patients who receive Empagliflozin (10 mg once daily from Abidi Company) in addition to their MDD standard treatment( Citalopram 40 mg once daily) for 2 months; both as oral agent. Hamilton score. Timepoint: 1st visit and 4 and8 weeks after Empagliflozin/Placebo administration. Method of measurement: Hamilton score questionnaire. Hamilton score. Timepoint: 1st day 4th week and 8th week after administration of Empagliflozin /Placebo. Method of measurement: 24 question Hamilton test. Research deputy of Alborz university of medical sciences Approved 2021-12-19 Ethics committee of Alborz University of Medical Sciences vice president for research of Alborz university of medical sciences, Saffarian alley, Golshahr St., Karaj Karaj Alborz Iran (Islamic Republic of)