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Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

Primary Purpose

Schizophrenia, Dyslipidemias

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Vildagliptin 50 MG
Placebo
Sponsored by
Sadat City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60.

Exclusion Criteria:

  • liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus

Sites / Locations

  • Faculty of PharmacyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vildagliptin

Placebo

Arm Description

Vildagliptin 50 mg tablet daily

Placebo tablet daily

Outcomes

Primary Outcome Measures

low-density lipoprotein cholesterol
low-density lipoprotein cholesterol

Secondary Outcome Measures

high-density lipoprotein cholesterol
high-density lipoprotein cholesterol
Serum stem cell growth factor beta
Serum stem cell growth factor beta
FAM19A5 serum level
FAM19A5 serum level
TNF-alpha serum level
TNF-alpha serum level
Adverse drug reactions
Adverse drug reactions

Full Information

First Posted
February 16, 2021
Last Updated
April 10, 2023
Sponsor
Sadat City University
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1. Study Identification

Unique Protocol Identification Number
NCT04761861
Brief Title
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia
Official Title
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
Vildagliptin 50 mg tablet daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet daily
Intervention Type
Drug
Intervention Name(s)
Vildagliptin 50 MG
Intervention Description
Vildagliptin 50 MG tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo one tablet daily
Primary Outcome Measure Information:
Title
low-density lipoprotein cholesterol
Description
low-density lipoprotein cholesterol
Time Frame
week 12
Secondary Outcome Measure Information:
Title
high-density lipoprotein cholesterol
Description
high-density lipoprotein cholesterol
Time Frame
week 12
Title
Serum stem cell growth factor beta
Description
Serum stem cell growth factor beta
Time Frame
week 12
Title
FAM19A5 serum level
Description
FAM19A5 serum level
Time Frame
12 weeks
Title
TNF-alpha serum level
Description
TNF-alpha serum level
Time Frame
12 weeks
Title
Adverse drug reactions
Description
Adverse drug reactions
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
body mass index
Description
body mass index
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia dyslipidemia after antipsycotic treatment the duration of illness was less than 12 months taking only one antipsychotic stable outpatient the total score of Positive and Negative Syndrome Scale (PANSS)≤60. Exclusion Criteria: liver or renal diseases pregnant or lactating women cardiovascular diseases hypertension or diabetes mellitus
Facility Information:
Facility Name
Faculty of Pharmacy
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abdallah, PhD
Phone
01063340887
Email
Mahmoud.samy@fop.usc.edu.eg
Phone
+201063340887
Email
Mahmoud.samy@fop.usc.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

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