Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women
NCT ID: NCT01041092
Last Updated: 2009-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
34 participants
INTERVENTIONAL
2004-06-30
2009-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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sugar pill
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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.
40 Years
FEMALE
No
Sponsors
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Fundació Sant Joan de Déu
OTHER
Locations
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Fundació Sant Joan de Déu
Esplugues de Llobregat, , Spain
Countries
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References
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Huerta-Ramos E, Iniesta R, Ochoa S, Cobo J, Miquel E, Roca M, Serrano-Blanco A, Teba F, Usall J. Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. Eur Neuropsychopharmacol. 2014 Feb;24(2):223-31. doi: 10.1016/j.euroneuro.2013.11.012. Epub 2013 Dec 1.
Usall J, Huerta-Ramos E, Iniesta R, Cobo J, Araya S, Roca M, Serrano-Blanco A, Teba F, Ochoa S. Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Nov;72(11):1552-7. doi: 10.4088/JCP.10m06610. Epub 2011 Aug 23.
Other Identifiers
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04T-504
Identifier Type: -
Identifier Source: org_study_id