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Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?

NCT01481883 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-11-28

No results posted yet for this study

Summary

The aim of this project is to investigate the effect of Raloxifene 120mg in men with schizophrenia. This trial will adopt a 12 week randomised controlled model.

Hypotheses 1: That the men receiving adjunctive selective estrogen receptor modulators (SERM) will have a significantly greater reduction in psychosis symptoms over the course of the study than men receiving adjunctive placebo.

Hypotheses 2: That the men receiving adjunctive SERM will have a significantly greater improvement in cognitive function than men receiving adjunctive placebo

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder

Interventions

DRUG

Raloxifene Hydrochloride

120mg daily - 1 capsule daily for 12 week trial

DRUG

Placebo

1 capsule daily for 12 week trial

Sponsors & Collaborators

  • The Alfred

    lead OTHER

Principal Investigators

  • Jayashri Kulkarni, Phd,FRANZCP · Monash Alfred Psychiatry Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2019-01-31
Completion
2019-02-28

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

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 NCT01481883 on ClinicalTrials.gov