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

• ClinicalTrials.gov Identifier: NCT01041092
• Recruitment Status: Completed
• First Posted: December 31, 2009
• Last Update Posted: December 31, 2009
• Sponsor: Fundació Sant Joan de Déu
• Information provided by: Fundació Sant Joan de Déu

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: raloxifene	Phase 4

Study Design

• 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

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures :

1. The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.

Secondary Outcome Measures :

1. Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Spain

Fundació Sant Joan de Déu

Esplugues de Llobregat, Spain

Sponsors and Collaborators

Fundació Sant Joan de Déu

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum In: Eur Neuropsychopharmacol. 2015 Jun;25(6):966.

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.

• Responsible Party: Fundació Sant Joan de Deu
• ClinicalTrials.gov Identifier: NCT01041092
• Other Study ID Numbers: 04T-504
• First Posted: December 31, 2009
• Last Update Posted: December 31, 2009
• Last Verified: December 2009

Additional relevant MeSH terms:

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