Novel Candidate Genes for Treatment Response to Antipsychotics in Schizophrenia

Schizophrenia Clinical Trial

— GEXANT  

Official title:

Novel Candidate Genes for Treatment Response to Antipsychotics in Schizophrenia: Evidence From Pharmacogenetics in the Light of Personalized Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02205437
• Other study ID #: GEXANT
• Status: Recruiting
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Fundación Marques de Valdecilla
• Contact: Benedicto Crespo-Facorro, Professor
• Phone: +34 942202545
• Email: benedicto.crespo[@]unican.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Spain	University Hospital Marques de Valdecilla	Santander	Cantabria

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Marques de Valdecilla	Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement.	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.	1 year.
Secondary	Changes in metabolic parameters.	This parameters are Cholesterol, Triglycerides, Glucose and Homeostasis model assessment (HOMA) index.	1 year.
Secondary	Effect of gender and cannabis use in the profile of gene expression associated with schizophrenia.		1 year.