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Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women

NCT01573637 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-04-22

No results posted yet for this study

Summary

The efficacy of raloxifene versus placebo was compared over a six-month period, as an adjuvant treatment of the negative symptoms of schizophrenia in a group of 80 post-menopausal women. The aim of the study is to analyze whether raloxifene has an effect on the positive and negative symptoms of schizophrenia, and on psychopathological symptoms in general, and on social and neuropsychological functioning, and to study the influence of genetic polymorphisms in treatment response.

Conditions

  • Schizophrenia in Post Menopausal Women

Interventions

DRUG

Raloxifene

The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.

DRUG

Lactosa (placebo arm)

Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.

Sponsors & Collaborators

  • Hospital Sant Joan de Deu

    collaborator OTHER

  • Parc Sanitari Sant Joan de Déu

    collaborator OTHER

  • Stanley Medical Research Institute

    collaborator OTHER

  • Fundació Sant Joan de Déu

    lead OTHER

Principal Investigators

  • Judith Usall, PhMD · Parc Sanitari Sant Joan de Déu

  • Javier Labad Arias, PhMD · Hospital Psiquiàtric Institut Pere Mata de Reus

  • Gemma García-Parés, PhMD · Corporació Sanitária Parc Taulí

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01573637 on ClinicalTrials.gov