Selective Estrogen Receptor Modulators - A Potential Treatment for Psychotic Symptoms of Schizophrenia
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
The Alfred
Collaborators:
National Health and Medical Research Council, Australia Stanley Medical Research Institute