Schizophrenia
Conditions
Interventions
Trade Name: Olanzapine
Product Name: Olanzapine
Pharmaceutical Form: Tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Concentration unit: mg milligram(s)
Concentration type: range
Concen
Sponsors
Fundación para la Investigación e Innovación Biosanitaria de Asturias (FINBA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent signature 2.Age =18 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Contraindications for treatment with olanzapine or aripiprazole 2.Electroconvulsive therapy in the current episode. 3.Psychopharmacological treatments (other than benzodiazepines) in the month prior to the inclusion of the study 4.During the study, the patient may only be in pharmacological treatment with one of the two antipsychotics under study (Olanzapine or Aripiprazole) and may only receive psychopharmacological treatment concomitant with the following benzodiazepines: dipotasic chloracepate and lormetazepam. 5.Subjects with a BMI outside the range 18.5-30.0. 6.Dependence or abuse of drugs (cannabis, opiates, cocaine or amphetamines) according to DSM-IVTR criteria. Patients may be included in which the use of drugs is sporadic and not usual 7.Alcohol consumption in the last month within the levels of risk to health (consumption = 35 U / week in men and = 21 U / week in women). 8.Women who are pregnant or breast-feeding. 9.Participation in another pharmacological research study in the previous 3 months. 10.Inability to understand information about the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To know the molecular mechanisms associated with the metabolic effects of antipsychotics in order to identify markers with clinical predictive value in the face of metabolic dysfunction induced by antipsychotics;Secondary Objective: -To know the genetic polymorphisms and the genetic variants associated with an increased risk of metabolic dysfunction. -To investigate the alterations of the mitochondrial physiology associated to the metabolic alterations induced by the antipsychotics. -To know the alterations of RNA and proteins associated with the metabolic alterations induced by antipsychotics. -Molecular alterations at the beginning of the treatment (at 72 hours, at the month and at 6 months after starting the treatment).;Primary end point(s): Metabolic change induced by second generation antipsychotics, evaluated by changes observed in complete laboratory tests performed on patients: -Glucose -LDL cholesterol -HDL cholesterol -Total Cholesterol -Triglycerides: -Glycosylated Hemoglobin -Bilirubin -Transaminases AST / GOT -ALT / GPT transaminases -Insulin -Peptide C -TSH Profile TSH Changes at the physiological level: -Measurements in the BMI, abdominal perimeter and waist - hip index. -Hepatic steatosis measured by the parameters obtained after performing a liver ecography: Liver Ecogeneity-Renal Cortex and the attenuation Index. -Glucose tolerance index;Timepoint(s) of evaluation of this end point: Six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Isolation of DNA to know the genetic polymorphisms and the genetic variants associated with an increased risk of metabolic dysfunction. 2.Analysis of the mitochondrial activity to know the alterations of the mitochondrial physiology associated to the metabolic alterations induced by the antipsychotics. 3.RNA isolation and measurement of proteins to know the alterations of RNA and proteins associated with the metabolic alterations induced by antipsychotics. 4.Plasma concentration of the drug, to know the molecular alterations induced by the treatment (at 72 hours, at month and at 6 months after starting the treatment);Timepoint(s) of evaluation of this end point: Six months | — |
Countries
Spain
Contacts
Public ContactYolanda Sanchez Carro
Instituto de Investigación Sanitaria del Hospital Universitario de La Princesa
Outcome results
None listed