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Evaluation effect of Empagliflozin in psychiatric disorders

Phase 3
Recruiting
Conditions
psychiatric disorders.
Registration Number
IRCT20180404039187N9
Lead Sponsor
Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

Aged 18 - 65 years old
Diagnosis of mental disorders with psychosis and psychotic disorders based on DSM-V-TR
Stable treatment with atypical antipsychotics (olanzapine, clozapine and risperidone) in the last 6 months (no dose change in the last 30 days)
Stable body weight (definition: less than 5% weight change in the last three months before the trial)
Body mass index greater than or equal to 25 (BMI=25)

Exclusion Criteria

Pregnancy and lactation
A recent history of drug abuse or dependence
Hepatic failure (increase in liver trans aminases to 2 times normal)
Renal insufficiency (GFR less than 30)
Having type 1 or 2 diabetes
Dysfunction of the pancreas
Cardiovascular disease
Uncontrollable blood pressure
Treatment with corticosteroids or other hormone therapy
Use medication to lose weight in the last 3 months

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
FBS. Timepoint: The beginning and the end of the study. Method of measurement: Laboratory tests (enzymatic).;Blood pressure. Timepoint: The beginning of the study, the fourth week, the eighth week and the end of the study. Method of measurement: using a sphygmomanometer.;Body weight. Timepoint: The beginning of the study, the fourth week, the eighth week and the end of the study. Method of measurement: Using digital scale.;Waist circumference. Timepoint: The beginning of the study, the fourth week, the eighth week and the end of the study. Method of measurement: Using a plastic meter.;LDL-HDL-TG. Timepoint: The beginning and the end of the study. Method of measurement: Laboratory tests (enzymatic).
Secondary Outcome Measures
NameTimeMethod
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