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

Fundació Sant Joan de Déu

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: raloxifene

Study type: Interventional

Funder types: Other

Identifiers

NCT01041092

04T-504

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

sugar pill

Placebo Comparator group

Treatment:

Drug: raloxifene

raloxifene hydrochloride

Active Comparator group

Description:

Dose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks.

Treatment:

Drug: raloxifene