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NCT04761861 Clinical Trial

Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

Schizophrenia Clinical Trial

Official title:
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04761861
Other study ID # 10/2021NEUR
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 16, 2021
Est. completion date December 31, 2025

Study information
Verified date April 2023
Source Sadat City University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-?) 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vildagliptin 50 MG
Vildagliptin 50 MG tablet once daily
• Placebo
Placebo one tablet daily

Locations
Country Name City State
Egypt Faculty of Pharmacy Shibin Al Kawm Menoufia

Sponsors (1)
Lead Sponsor Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Other body mass index body mass index 12 weeks
Primary low-density lipoprotein cholesterol low-density lipoprotein cholesterol week 12
Secondary high-density lipoprotein cholesterol high-density lipoprotein cholesterol week 12
Secondary Serum stem cell growth factor beta Serum stem cell growth factor beta week 12
Secondary FAM19A5 serum level FAM19A5 serum level 12 weeks
Secondary TNF-alpha serum level TNF-alpha serum level 12 weeks
Secondary Adverse drug reactions Adverse drug reactions 12 weeks
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