determination of Empagiflozin effect as an adjunct therapy for treatment of Major depressive disorder

Phase 3

• Conditions: Major depression disorder.; Major depressive disorder, single episode, severe without psychotic features; F32.2

• Registration Number: IRCT20200805048313N1
• Lead Sponsor: Karaj University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

patients with MDD based on DSM V criteria while Hamilton score is equal to 22 or more than 22.

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton score. Timepoint: 1st visit and 4 and8 weeks after Empagliflozin/Placebo administration. Method of measurement: Hamilton score questionnaire.

Secondary Outcome Measures

Name	Time	Method
Hamilton score. Timepoint: 1st day 4th week and 8th week after administration of Empagliflozin /Placebo. Method of measurement: 24 question Hamilton test.