Back to resultsEmpagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
Primary Purpose
Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Empagliflozin
olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 as control group
Group two as Empagliflozin
Arm Description
Outcomes
Primary Outcome Measures
Change in body weight and body mass index (BMI)
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
any side effects of the used intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05669742
Brief Title
Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 as control group
Arm Type
Active Comparator
Arm Title
Group two as Empagliflozin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Description
sodium-glucose transport protein two inhibitor
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
antipsychotics
Primary Outcome Measure Information:
Title
Change in body weight and body mass index (BMI)
Description
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
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Adverse events (AE) as measures of safety and tolerability of Empagliflozin
Description
any side effects of the used intervention
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
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