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

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

Tracking Information
First Submitted Date  ICMJE December 30, 2009
First Posted Date  ICMJE December 31, 2009
Last Update Posted Date December 31, 2009
Study Start Date  ICMJE June 2004
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2009)
Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2009)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01041092
Other Study ID Numbers  ICMJE 04T-504
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fundació Sant Joan de Deu
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fundació Sant Joan de Déu
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundació Sant Joan de Déu
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP