N/A
N=328
An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Schizophrenia · Metabolic Syndrome X
Bottom Line
View on ClinicalTrials.gov: NCT00448630 ↗Enrolled (actual)
328
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Metabolic Syndrome Parameter Body Mass Index (BMI) — 26.3; 26.6; 26.9 kg/m*m (kilograms per meter squared) — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Syndrome Parameter Body Mass Index (BMI) |
26.3; 26.6; 26.9 | <0.001 sig |
| PRIMARY Metabolic Syndrome Parameter Body Weight |
74.27; 75.06; 76.18 | <0.001 sig |
| PRIMARY Metabolic Syndrome Parameter Waist Circumference |
91.92; 92.07; 92.80 | <0.001 sig |
| PRIMARY Metabolic Syndrome Parameter Fasting Blood Sugar |
80.82; 77.64; 76.79 | 0.544 |
| PRIMARY Metabolic Syndrome Parameter Total Cholesterol |
178.48; 181.81; 179.67 | 0.245 |
| PRIMARY Metabolic Syndrome Parameter Low Density Lipoprotein (LDL) |
118.71; 122.56; 122.86 | 0.362 |
| PRIMARY Metabolic Syndrome Parameter High Density Lipoprotein (HDL) |
35.11; 36.99; 35.51 | 0.176 |
| PRIMARY Metabolic Syndrome Parameter Triglycerides |
115.11; 116.46; 127.63 | <0.001 sig |
| SECONDARY Metabolic Syndrome Parameter BMI by Treatment Group |
26.12; 26.17; 26.94; 24.06; 29.76; 24.92 | 0.490 |
| SECONDARY Metabolic Syndrome Parameter Weight by Treatment Group |
73.11; 72.39; 76.22; 69.82; 84.26; 70.68 | 0.524 |
| SECONDARY Metabolic Syndrome Parameter Waist Circumference by Treatment Group |
91.18; 91.55; 93.75; 89.04; 96.64; 88.80 | 0.197 |
| SECONDARY Metabolic Syndrome Parameter Triglycerides by Treatment Group |
104.89; 129.66; 117.92; 86.24; 113.79; 142.75 | 0.077 |
Summary
The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.
Eligibility Criteria
Inclusion Criteria
- Female and male patients diagnosed as schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders.
- Age between 18-45 years
- Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians.
Exclusion Criteria
- Patients who are pregnant or considering pregnancy.
Data sourced from ClinicalTrials.gov (NCT00448630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.