Vildagliptin for Treatment of Antipsychotic-induced Dyslipidemia
Phase 2
Recruiting
- Conditions
- SchizophreniaDyslipidemias
- Interventions
- Drug: Placebo
- Registration Number
- NCT04761861
- Lead Sponsor
- Sadat City University
- 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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vildagliptin Vildagliptin 50 MG Vildagliptin 50 mg tablet daily Placebo Placebo Placebo tablet daily
- Primary Outcome Measures
Name Time Method low-density lipoprotein cholesterol week 12 low-density lipoprotein cholesterol
- Secondary Outcome Measures
Name Time Method TNF-alpha serum level 12 weeks TNF-alpha serum level
high-density lipoprotein cholesterol week 12 high-density lipoprotein cholesterol
Adverse drug reactions 12 weeks Adverse drug reactions
FAM19A5 serum level 12 weeks FAM19A5 serum level
Serum stem cell growth factor beta week 12 Serum stem cell growth factor beta
Trial Locations
- Locations (1)
Faculty of Pharmacy
🇪🇬Shibīn Al Kawm, Menoufia, Egypt