Schizophrenia Clinical Trial
Official title:
Double Blind, Placebo-controlled Study of Efficacy, Safety and Tolerance of Raloxifene as an Adjuvant Treatment for Negative Symptoms of Schizophrenia in Postmenopausal Women
Verified date | December 2009 |
Source | Fundació Sant Joan de Déu |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
Primary objective: To assess the efficacy of adding raloxifene as an adjunct to
antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal
women.
This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant
treatment to antipsychotic treatment. Treatment period of 12 weeks.
The primary result obtained is that women treated with 60 mg of raloxifene compared to those
treated with a placebo show greater improvement in psychotic symptoms. The investigators
also found improved response in some aspects of social functioning and neuropsychological
functioning.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Fundació Sant Joan de Déu | Esplugues de Llobregat |
Lead Sponsor | Collaborator |
---|---|
Fundació Sant Joan de Déu |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment. | |||
Secondary | Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point. |
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