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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200805048313N1
Enrollment
80
Registered
2022-02-10
Start date
2022-04-19
Completion date
Unknown
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depression disorder. Major depressive disorder, single episode, severe without psychotic features

Interventions

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 MD
both as oral agent.

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

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 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

Design outcomes

Primary

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

Secondary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Atefeh Zandifar

Karaj University of Medical Sciences

mary.pn96@gmail.com+98 21 8897 5154

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026