Novel Candidate Genes for Treatment Response to Antipsychotics in Schizophrenia

NCT ID: NCT02205437

Last Updated: 2020-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Schizophrenia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Controls

Healthy subjects without psychotic disorder.

No interventions assigned to this group

Drug-naive patients

Drug-naive (never medicated) schizophrenia patients.

No interventions assigned to this group

Patients responder to treatment

Patients with a good clinical response to treatment (define by a marked improvement of positive symptoms) at 3 months and at 1 year.

No interventions assigned to this group

Patients non-responder to treatment

Patients with a poor clinical response to treatment at 3 months and at 1 year.

No interventions assigned to this group

Patients with metabolic side effects

Patients with metabolic side effects associated to treatment.

No interventions assigned to this group

Patients with non-metabolic side effects

Patients with no metabolic side effects associated to treatment.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro de Investigación Biomédica en Red de Salud Mental

NETWORK

Sponsor Role: collaborator

Instituto de Investigación Marqués de Valdecilla

OTHER

Sponsor Role: collaborator

Fundación Marques de Valdecilla

OTHER

Sponsor Role: lead

Responsible Party

Benedicto Crespo-Facorro

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benedicto Crespo-Facorro, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain

Locations

University Hospital Marques de Valdecilla

Santander, Cantabria, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Benedicto Crespo-Facorro, Professor

Role: CONTACT

benedicto.crespo@unican.es

+34 942202545

Other Identifiers

GEXANT

Identifier Type: -

Identifier Source: org_study_id