Using vildagliptin to treat cholesterol issues caused by antipsychotic medications
Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia: a Randomized, Double-blind, Placebo-controlled Study
This study is testing if vildagliptin can help people with schizophrenia who have high cholesterol from their antipsychotic medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Sadat City University Academic / other |
| Locations | 1 site (Shibīn Al Kawm, Menoufia) |
| Trial ID | NCT04761861 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of vildagliptin, a medication known to improve lipid levels, in patients experiencing dyslipidemia as a side effect of antipsychotic treatment for schizophrenia. It is a randomized, placebo-controlled Phase 2 trial, meaning participants will be assigned to receive either vildagliptin or a placebo to assess the drug's effectiveness. The study focuses on patients who have been diagnosed with schizophrenia and have developed dyslipidemia within the last 12 months while on a stable dose of a single antipsychotic. The goal is to determine if vildagliptin can effectively manage lipid levels in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with schizophrenia who have developed dyslipidemia after starting antipsychotic treatment within the last year.
Not a fit: Patients with liver or renal diseases, cardiovascular diseases, hypertension, diabetes mellitus, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help manage cholesterol levels in patients with schizophrenia who are affected by antipsychotic-induced dyslipidemia.
How similar studies have performed: While there is limited data on the use of vildagliptin specifically for this purpose, the approach of addressing dyslipidemia in patients on antipsychotics is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shibīn Al Kawm, Menoufia
- Faculty of Pharmacy — Shibīn Al Kawm, Menoufia, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.