Clinical trial NCT01041092: Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2009-12-31
Enrollment: 34
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
Secondary outcomes:
measure: Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Fundació Sant Joan de Déu
Study officials:
References:
citation: 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.
citation: 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.