CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 78 enrolled
Drug / intervention
Raloxifene +1 moredrug
Likely dose
Raloxifene 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01573637
NCT01573637Phase 3Completed
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Six Month, Double Blind, Placebo-controlled Trial of the Efficacy of Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women

Fundació Sant Joan de Déu·interventional·Posted Apr 9, 2012·Updated Apr 22, 2024

In Brief

A Phase 3 clinical trial evaluating Raloxifene and Lactosa (placebo arm) for Schizophrenia in Post Menopausal Women. Completed, enrolled 78 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia in Post Menopausal Women
CountriesSpain
CollaboratorsHospital Sant Joan de Deu, Parc Sanitari Sant Joan de Déu, Stanley Medical Research Institute

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2012
Enrollment StartJul 1, 2011
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.2 years ago

Interventions

Raloxifenedrug

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.

Lactosa (placebo arm)drug

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.