Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women

Launched by FUNDACIÓ SANT JOAN DE DÉU · Dec 30, 2009

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of schizophrenia (DSM-IV criteria)
• • Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level \> 20IU/L.
• • Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
• • Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
• • Patients have to give written informed consent to participate in the study.
• Exclusion Criteria:
• • Patients with a substance abuse/dependence diagnosis in the previous six months.
• • Mental retardation.
• • Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
• • History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
• • Patients taking hormone replacement therapy.
• • Patients taking mood stabilizer medication that cannot be discontinued.