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

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05669742

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics	Drug: Empagliflozin Drug: olanzapine	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Evaluating the Safety and Efficacy of Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients.A Double-Blind, Randomized, Placebo-Controlled Trial

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 as control group	Drug: olanzapine antipsychotics
Active Comparator: Group two as Empagliflozin	Drug: Empagliflozin sodium-glucose transport protein two inhibitor

Arm

Intervention/Treatment

Active Comparator: Group 1 as control group

Drug: olanzapine

antipsychotics

Active Comparator: Group two as Empagliflozin

Drug: Empagliflozin

sodium-glucose transport protein two inhibitor

Outcome Measures

Primary Outcome Measures

Change in body weight and body mass index (BMI) [up to 12 weeks]
a person's weight in kilograms (or pounds) divided by the square of height in meters and measure of body fat based on height and weight that applies to adult men and women body mass index = wt (kilogram) divideed by height in meter square

Secondary Outcome Measures

Adverse events (AE) as measures of safety and tolerability of Empagliflozin [up to 12 weeks]
any side effects of the used intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Elberri, Lecturer of Clinical Pharmacy, Tanta University

ClinicalTrials.gov Identifier:

NCT05669742

Other Study ID Numbers:

EMPA2022

First Posted:

Jan 3, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Schizophrenia

Empagliflozin

Olanzapine

Study Results

No Results Posted as of Jan 25, 2023