Evaluation effect of Empagliflozin in psychiatric disorders

The study of efficacy of Empagliflozin on metabolic effects of atypical antipsychotic drugs in patients with psychiatric disorders: a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180404039187N9

Enrollment

Registered

2021-12-18

Start date

2021-12-06

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

psychiatric disorders.

Interventions

Intervention 1: Intervention group: Take atypical antipsychotic drugs such as olanzapine, clozapine and risperidone with ampagliflozin 10 mg daily. Intervention 2: Control group: Atypical antipsychoti

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Elnaz Shaseb

Tabriz University of Medical Sciences

elnaz_shaseb_64@yahoo.com+98 41 3334 1449

Outcome results

None listed

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