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

The aim of this study is determination of Empagliflozin effect as an adjunct therapy for treatment of MDD, comparison between the treatment of patients who received Empagliflozin and placebo

The clinical trial is randomized double-blind . The sample size is 80 people, half of them will receive citalopram plus Empagliflozin and the other half will receive citalopram plus placebo.

This clinical trial is carried out in psychiatric clinic of Imam Ali Hospital , MDD known cases with inclusion criteria and w/o exclusion criteria will be chosen and as a randomized double blinded trial (physician and patient do not know which category the patient is) half of patients receive Citalopram and Empagliflozin and the other half receive Citalopram and Placebo.and their Ham score is assessed in weeks 0 4 8.

inclusion requirements: MDD diagnosed (Ham. score>22) exclusion requirements: Psychotic/Other disorders in axes I or II/Psychotropic medicine/Anti depressant agents use during last one month and ECT during last 2 months. Hypothyroidism/Cardiovascular disease history/Pregnancy or breast feeding Kidney disease/DM type 1/age<18 or >60/IQ<70/seizure and neurologic disorders/Betablockers use/Drug abuse except nicotine and caffeine/ UTI/Mao inhibitors use such as Azilect ,Marplan ,Aspirin ,Gabapentin , Pantoprazole ,Omeprazole/Pancreatitis/Hypotension

40 volunteers receive daily Citalopram and Empagliflozin and 40 volunteers receive daily Citalopram and Placebo. .Their Hamilton score will be evaluated in Weeks 0 and 4 and 8 . The change in depression severity is assessed using Hmailton test during 2 months.

Hamilton's score is the main variable of the study and determines the effectiveness of the drug and shows us how well the patient's depression has improved.

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.

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.

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.

Public access will be established up to six months after the end of the study.

The public and those interested in scientific information will have access to this trial findings.

All statistical analysis and classified information will be provided to them.

If requested, please refer to mary.pn96@gmail.com e-mail.

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.