Schizophrenia
Conditions
Keywords
Schizophrenia, Psychosis, Antipsychotics, Treatment response, Metabolic side effects, Gene expression, RNA, Genes
Brief summary
Schizophrenia is a severe and chronic mental disorder. The lifetime risk of schizophrenia is around 1%. Its course is chronic and frequently disabling. The keystone of schizophrenia treatment is antipsychotic medications. The use of antipsychotics represents a huge public health and economic burden to society. Most of antipsychotics drugs are metoo drugs, directly or indirectly replicating dopamine D2 receptor blockade. Pharmaceutical companies have aimed to produce drugs with a general indication for all patients with schizophrenia with a one-size-fits-all strategy with no targeting or stratification. Second generation antipsychotics partly improve positive symptoms and are quite often associated to weight gain, metabolic changes and increased risk of cardiovascular diseases. Antipsychotics only achieve a certain degree of clinical improvement in a percentage of patients (45%) and 30% of the patients are treatment resistant. In light of the current deadlock, there is an urgent need to expand the horizon of pharmacological research by elucidating new mechanisms related to antipsychotic actions. An alternative strategy is the comparison of gene expression profiles in drug-naive accurately ill patients before and after antipsychotic treatment has been initiated. Our research group has a great experience in the field and has been working on this hypothesis in the latest years. We propose a continuation project to thoroughly explore the clinical implications (clinical response to antipsychotic drugs or emergence of metabolic side effects) of the variants in gene expression we have recently described in schizophrenia patients. This project takes advantage of an exceptional (regarding to the detailed knowledge of clinical outcome and side effect profile) longitudinal cohort of drug-naive patients with schizophrenia who had been followed up for three years at the University Hospital Marqués de Valdecilla.
Interventions
None listed
Sponsors
Centro de Investigación Biomédica en Red de Salud Mental
Instituto de Investigación Marqués de Valdecilla
Fundación Marques de Valdecilla
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients followed up for 3 years in the First Episode Psychosis Clinical Program (PAFIP). * 15-60 years. * Living in the catchment area. * Experiencing their first episode of psychosis. * No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks. * Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, or schizoaffective disorder.
Exclusion criteria
* Meeting DSM-IV criteria for drug dependence. * Meeting DSM-IV criteria for mental retardation. * Having a history of neurological disease or head injury.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement. | 1 year. | Changes in the total scores of the Scale for the Assessment of Positive Symptoms (SAPS) and Negative Symptoms (SANS), the Brief Psychiatric Rating Scale (BPRS) and the severity scale of the Clinical Global Impression (CGI) scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in metabolic parameters. | 1 year. | This parameters are Cholesterol, Triglycerides, Glucose and Homeostasis model assessment (HOMA) index. |
| Effect of gender and cannabis use in the profile of gene expression associated with schizophrenia. | 1 year. | — |
Countries
Spain
Contacts
Primary ContactBenedicto Crespo-Facorro, Professor
Outcome results
None listed