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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01041092
Other study ID # 04T-504
Secondary ID
Status Completed
Phase Phase 4
First received December 30, 2009
Last updated December 30, 2009
Start date June 2004
Est. completion date December 2009

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
raloxifene
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.

Locations

Country Name City State
Spain Fundació Sant Joan de Déu Esplugues de Llobregat

Sponsors (1)

Lead Sponsor Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

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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