The Use of Selective Estrogen Receptor Modulators in the Treatment of Schizophrenia- a Pilot Study
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
The aim of the project is to investigate the use of raloxifene (a new form of estrogen) as a
treatment for schizophrenia in postmenopausal women. Raloxifene is a selective estrogen
receptor modulator (SERM) which means that it can affect the central nervous system effects
of estrogen (eg: improving emotional symptoms, memory, information processing and
concentration), without adversely affecting reproductive tissue / organs such as breast,
uterus and ovaries.We are conducting a double blind placebo controlled 3 month duration study
comparing the psychotic symptom response between three groups of postmenopausal women with
schizophrenia. One group will receive standard antipsychotic medication plus 60mg Raloxifene,
the second group receives standard antipsychotic medication plus Hormone Therapy(estradiol
2mg oral per day + dyhydroprogesterone 10mg oral per day) and the third group receives
standard antipsychotic medication plus oral placebo. Hypothesis 1: That the women receiving
adjunctive raloxifene or HT 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 other two groups.