SNPMiner Trials (Home Page)
Report for SNP rs9340799
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 Six Month, Double Blind, Placebo-controlled Trial of the Efficacy of Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women
The efficacy of raloxifene versus placebo was compared over a six-month period, as an adjuvant treatment of the negative symptoms of schizophrenia in a group of 80 post-menopausal women. The aim of the study is to analyze whether raloxifene has an effect on the positive and negative symptoms of schizophrenia, and on psychopathological symptoms in general, and on social and neuropsychological functioning, and to study the influence of genetic polymorphisms in treatment response.
NCT01573637 Negative Symptoms of Schizophrenia in Post-menopausal Women. Drug: Raloxifene Drug: Lactosa (placebo arm) MeSH:Schizophrenia
HPO:Schizophrenia
Genotypic studies will be conducted of the 4 SNPs in the ESR1 (rs9340799, rs2234693, rs1801132) and ESR2 (rs1256049) genes, to control the effects of patients' genotypes on response to treatment.
Primary Outcomes
Description: The primary variable of efficacy will correspond to the change in score on the negative subscale of the PANSS from the start of treatment to the final assessment at 24 weeks. Patients will be considered to respond to treatment if the score in the negative subscale is at least 20% lower than at the start of treatment.
Measure: To assess the efficacy of raloxifene (SERM - Selective Estrogen Receptor Modulator) as an adjuvant of antipsychotic treatment in the management of negative symptoms of schizophrenia in post-menopausal women. Time: Change in score on the negative subscale of the PANSS from baseline to final assessment at week 24Secondary Outcomes
Description: The results from different scales or test will be measured: at baseline,week 4,12 y 24 for scales (PANSS, SANS, CGI, GAF, CDSS -Calgary, LSP, SIMPSON, UKU, DAS-sv) and at baseline, week 12 and 24 for neuropsychological test (TAVEC, CPT, TMT, STROOP, FAS, WAIS sub-tests).
Measure: To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the management of global symptoms of schizophrenia in postmenopausal women. Time: From baseline to week 24 (measurements at Baseline, weeks 4, 12, 24)Description: The results from different scales or test will be measured: at baseline,week 4,12 y 24 for scales (PANSS, SANS, CGI, GAF, CDSS -Calgary, LSP, SIMPSON, UKU, DAS-sv) and at baseline, week 12 and 24 for neuropsychological test (TAVEC, CPT, TMT, STROOP, FAS, WAIS sub-tests).
Measure: To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the global functioning of postmenopausal women with schizophrenia. Time: From baseline to week 24 (measurements at Baseline, weeks 4, 12, 24)Description: The results from different test will be measured at weeks, baseline, 12 and 24 for neuropsychological test (TAVEC, CPT, TMT, STROOP, FAS, WAIS sub-tests).
Measure: To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the neuropsychological functioning of post-menopausal women with schizophrenia Time: From baseline to week 24 (measurements at Baseline, week 12, week 24)Description: Analysis will be done for patients who consented by the Informed Consent Form. The analysis will be carried out by centralized laboratory (Biobanc Institut d´Investigació Sanitària Pere Virgili; Reus, Spain) once all samples will be collected. In the meantime, the samples will be kept frozen at 4oC.
Measure: To control response to treatment as a function of genetic variants in the form of SNP (Single Nucleotide Polymorphisms) that patients present in the alfa (ESR1) and beta (ESR2) estrogenic receptor genes. Time: Blood sample collected at Baseline visitDescription: Safety will be assessed during the study by the vigilance of the AEs, SAEs, AR, SARs at each visit. Blood analysis (hemo/chem) will be done at Baseline and at the end (week 24), and clinical scales will be measured at Baseline, week 4,12 y 24 (PANSS, SANS, CGI, GAF, CDSS -Calgary, LSP, SIMPSON, UKU, DAS-sv)
Measure: To assess the safety of the medication used in this patient population. Time: From Baseline to week 24