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

This study has been completed.
Sponsor:
Information provided by:
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT01041092
First received: December 30, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: raloxifene
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Fundació Sant Joan de Déu:

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.

Enrollment: 34
Study Start Date: June 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041092

Locations
Spain
Fundació Sant Joan de Déu
Esplugues de Llobregat, Spain
Sponsors and Collaborators
Fundació Sant Joan de Déu
  More Information

No publications provided by Fundació Sant Joan de Déu

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

Responsible Party: Fundació Sant Joan de Deu
ClinicalTrials.gov Identifier: NCT01041092     History of Changes
Other Study ID Numbers: 04T-504
Study First Received: December 30, 2009
Last Updated: December 30, 2009
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Raloxifene
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 16, 2013