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Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761861
Enrollment
0
Registered
2021-02-21
Start date
2021-02-16
Completion date
2025-12-31
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Dyslipidemias

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.

Interventions

Vildagliptin 50 MG tablet once daily

DRUGPlacebo

Placebo one tablet daily

Sponsors

Sadat City University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
low-density lipoprotein cholesterolweek 12low-density lipoprotein cholesterol

Secondary

MeasureTime frameDescription
Serum stem cell growth factor betaweek 12Serum stem cell growth factor beta
high-density lipoprotein cholesterolweek 12high-density lipoprotein cholesterol
TNF-alpha serum level12 weeksTNF-alpha serum level
Adverse drug reactions12 weeksAdverse drug reactions
FAM19A5 serum level12 weeksFAM19A5 serum level

Other

MeasureTime frameDescription
body mass index12 weeksbody mass index

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026