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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
raloxifene
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundació Sant Joan de Déu

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

sugar pill

raloxifene hydrochloride

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
December 30, 2009
Last Updated
December 30, 2009
Sponsor
Fundació Sant Joan de Déu
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1. Study Identification

Unique Protocol Identification Number
NCT01041092
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fundació Sant Joan de Déu

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Title
raloxifene hydrochloride
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
raloxifene
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fundació Sant Joan de Déu
City
Esplugues de Llobregat
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24342775
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. Erratum In: Eur Neuropsychopharmacol. 2015 Jun;25(6):966.
Results Reference
derived
PubMed Identifier
21903021
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.
Results Reference
derived

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

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