Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

NCT04761861 | Withdrawn Phase 2

• 1 other identifier: 10/2021NEUR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• low-density lipoprotein cholesterol

  low-density lipoprotein cholesterol

  week 12

Secondary Outcomes (5)

• high-density lipoprotein cholesterol

  week 12

• Serum stem cell growth factor beta

  week 12

• FAM19A5 serum level

  12 weeks

• TNF-alpha serum level

  12 weeks

• Adverse drug reactions

  12 weeks

Other Outcomes (1)

• body mass index

  12 weeks

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Vildagliptin 50 mg tablet daily

Drug: Vildagliptin 50 MG

Placebo

PLACEBO COMPARATOR

Placebo tablet daily

Drug: Placebo

Interventions

Vildagliptin 50 MG DRUG

Vildagliptin 50 MG tablet once daily

Vildagliptin

Placebo DRUG

Placebo one tablet daily

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

Faculty of Pharmacy

Shibīn al Kawm, Menoufia, 13829, Egypt

Location

MeSH Terms

Conditions

Schizophrenia; Dyslipidemias

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: February 16, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)