Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women
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ClinicalTrials.gov Identifier: NCT01041092 |
Recruitment Status :
Completed
First Posted : December 31, 2009
Last Update Posted : December 31, 2009
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: raloxifene | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: sugar pill |
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. |
Active Comparator: raloxifene hydrochloride
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.
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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. |
- The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
- Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041092
Spain | |
Fundació Sant Joan de Déu | |
Esplugues de Llobregat, Spain |
Responsible Party: | Fundació Sant Joan de Deu |
ClinicalTrials.gov Identifier: | NCT01041092 |
Other Study ID Numbers: |
04T-504 |
First Posted: | December 31, 2009 Key Record Dates |
Last Update Posted: | December 31, 2009 |
Last Verified: | December 2009 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Raloxifene Hydrochloride Estrogen Antagonists Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents |