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

Tracking Information

• First Submitted Date: December 30, 2009
• First Posted Date: December 31, 2009
• Last Update Posted Date: December 31, 2009
• Study Start Date: June 2004
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 30, 2009): The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: December 30, 2009): Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Schizophrenia

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.

Study Arms

• Placebo Comparator: sugar pill
  Intervention: Drug: raloxifene
• 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.
  Intervention: Drug: raloxifene

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 30, 2009): 34
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT01041092
• Other Study ID Numbers: 04T-504
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fundació Sant Joan de Deu
• Original Responsible Party: Same as current
• Current Study Sponsor: Fundació Sant Joan de Déu
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fundació Sant Joan de Déu
• Verification Date: December 2009