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Selective Estrogen Receptor Modulators - A Potential Treatment for Psychotic Symptoms of Schizophrenia?

This study is currently Recruiting

February 2011 By The Alfred

First Recieved on August 7, 2006

Last Updated on February 25, 2011

Sponsor: The Alfred
Collaborators: Stanley Medical Research Institute
Information provided by: The Alfred
Identifier: NCT00361543

Purpose

The aim of the project is to investigate the use of Raloxifene (a new form of estrogen) in the treatment of women with schizophrenia and schizoaffective disorder. Raloxifene is a Selective Estrogen Receptor Modulator (SERM), which means that it can affect the central nervous system (CNS) effects of estrogen (eg. improving emotional symptoms, memory, information processing and concentration), without adversely affecting reproductive tissue/organs such as breast, uterus and ovaries. The investigators are conducting a double-blind, placebo controlled, three month study comparing the psychotic symptom response of women with schizophrenia in both groups. One group will receive standard antipsychotic medication plus 120mg Raloxifene, while the second group will receive standard antipsychotic medication plus oral placebo. Hypothesis 1: That the women receiving adjunctive Raloxifene would have a quicker recovery from psychotic symptoms, as measured on the rating scales, compared with the women receiving adjunctive placebo. Hypothesis 2: That the Raloxifene group would have better cognitive improvement than the placebo group.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Female - Current diagnosis of DSM-IV Schizophrenia, Schizoaffective Disorder or Schizophreniform Disorder - Symptom rating greater than 60 on the PANSS at baseline/screening - Patient is able to give informed consent Exclusion Criteria: - Clinically significant concomitant medical or neurological condition or history of venous thromboembolic event - High suicide/aggression risk in the opinion of the investigator - If participant's illness is directly related to illicit substance abuse or has a history of substance abuse or dependence in the past six months - Smoking more than 20 cigarettes per day - Use of any form of hormones or hormone therapy - Illness causing immobilisation - Undiagnosed postmenopausal vaginal bleeding - Consumption of more than 30gm of alcohol (three standard drinks) per day

Investigators

  • Investigator: Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD - Principal Investigator - Bayside Health, Alfred Hospital

Locations

  • Alfred Psychiatry Research Centre

    Melbourne, Victoria 3004 Australia

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