Vildagliptin for Treatment of Antipsychotic-induced Dysli... | NCT04761861

Studies
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

NCT04761861

Sponsor

Sadat City University

Status

Withdrawn

Last Update Posted

Jul 14, 2025Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Schizophrenia
Dyslipidemias

Interventions

Vildagliptin 50 MG
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Institutional and funding constrains

Expanded Access Info

Start Date

Feb 16, 2021Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 16, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2025

Last Update Posted Date

Jul 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vildagliptin	Experimental	Vildagliptin 50 mg tablet daily	Drug: Vildagliptin 50 MG
Placebo	Placebo Comparator	Placebo tablet daily	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vildagliptin 50 MG	Drug	Vildagliptin 50 MG tablet once daily	Vildagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
low-density lipoprotein cholesterol	low-density lipoprotein cholesterol	week 12

Secondary Outcomes

Measure	Description	Time Frame
high-density lipoprotein cholesterol	high-density lipoprotein cholesterol	week 12
Serum stem cell growth factor beta	Serum stem cell growth factor beta

Other Outcomes

Measure	Description	Time Frame
body mass index	body mass index	12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Pharmacy		Shibīn al Kawm	Menoufia	13829	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077597	Vildagliptin

Ancestor Terms

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided