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

NCT ID: NCT05669742

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1 as control group

Group Type: ACTIVE_COMPARATOR

olanzapine

Intervention Type: DRUG

antipsychotics

Group two as Empagliflozin

Group Type: ACTIVE_COMPARATOR

Empagliflozin

Intervention Type: DRUG

sodium-glucose transport protein two inhibitor

Interventions

Empagliflozin

sodium-glucose transport protein two inhibitor

Intervention Type: DRUG

olanzapine

antipsychotics

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Schizophrenia Patients treated with Olanzapine with ages ranging from 18 to 60 years.

Exclusion Criteria

patients who had any other inflammatory disease (cardiovascular, asthma, bone

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Eman Elberri

Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EMPA2022

Identifier Type: -

Identifier Source: org_study_id