Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients

Conditions

• Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin — DRUG
  sodium-glucose transport protein two inhibitor
• olanzapine — DRUG
  antipsychotics

Study Details

Olanzapine is a thieno-benzodiazepine derivate that is effective managing the symptoms of schizophrenia and reducing the psychopathological symptoms of psychosis. It is also effective in controlling the acute manic episodes associated with bipolar disorder, and have provided some therapeutic advantages over other antipsychotic agents (Citrome et al., 2019). However, Ola administration has been reported to induce profound BWG accompanied with higher incidence of metabolic deficits, such as hypertension, diabetes and hyperlipidemia, as compared to other antipsychotic agents (Mauri et al., 2014). Adjunctive treatment with other agents that can minimize or normalize Ola-induced BWG can enhance the safety and tolerability profiles of an effective antipsychotic, thus highlighting the need to develop improved therapies or interventions to minimize these side effects. A meta-analysis of 12 published studies found that antidiabetic drugs such as metformin improved metabolic parameters in patients treated with antipsychotics (de Silva et al., 2016). These studies encouraged the evaluation of other antidiabetic agents as adjunctive therapies to minimize Ola-induced BWG. Empagliflozin (EMPA)is the third-generation anti-diabetic drug acting as sodium-glucose transport protein two inhibitor (SGLT2), which provides a new mechanism of action to improve glycemic control with modest decreases in systolic blood pressure and body weight (Pradhan et al., 2019). The effects of EMPA on Ola-induced BWG have not been determined and require further investigation.

Key Dates

Start date

May 25, 2023

Status verified

Feb 2026

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Group 1 as control group
• Active Comparator: Group two as Empagliflozin

Primary Outcome Measure

Change in body weight and body mass index (BMI) [ Time Frame: up to 12 weeks ]