Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal … (NCT01573637) | Clinical Trial Compass
CompletedPhase 3
Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women
Spain78 participantsStarted 2011-07
Plain-language summary
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.
Who can participate
Age range45 Years
SexFEMALE
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Inclusion criteria
✓. Diagnosis of schizophrenia according to DSM-IV TR criteria.
✓. Postmenopausal patients. Post-menopausal is defined as 1) aged over 45 years with at least one year of amenorrhea and levels of FSH over 20 UI/L or 2) aged over 50 years with at least one year of amenorrhea.
✓. Patients who have been taking a stable dose of antispsychotic medication for at least the 30 days before the start of the study.
✓. The presence of significant negative symptoms (defined as one or more negative symptoms with a severity of over 4 on the PANSS scale).
✓. General written informed consent by patients or their legal representative.
✓. For the genotypic study, a specific informed consent signed by the patients or legal representative is required.
Exclusion criteria
✕. A diagnosis of substance abuse/dependence in the previous 6 months.
✕. Mental retardation
✕. A diagnosis of major depression (according to DSM-IV TR criteria).
✕. Endocrine alterations related to sexual hormones, liver insufficiency including cholestasis, severe renal insufficiency.
✕. History or current condition of thromboembolism, breast cancer, abnormal uterine bleeding or stroke.
✕
What they're measuring
1
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.
Timeframe: Change in score on the negative subscale of the PANSS from baseline to final assessment at week 24