Adjunctive Selective Estrogen Receptor Modulators on Negative and Cognitive Symptoms of Schizophrenia in Women
Status:
Completed
Trial end date:
2019-07-30
Target enrollment:
Participant gender:
Summary
The aim of the project is to assess the efficacy of Adjunctive Selective Estrogen Receptor
Modulators (Raloxifene) on Negative and Cognitive symptoms of Schizophrenia in Postmenopausal
Women.
For postmenopausal women with schizophrenia, current research suggests that these people can
be treated with estrogen, which can reduce cardiovascular and reproductive tissue problems,
help sleep and improve mood. In addition, cognitive problems in this group of people can also
be helped. 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, 12 weeks study comparing the negative symptoms
and cognitive functions in postmenopausal women with schizophrenia in both groups. One group
will receive clozapine plus 60mg Raloxifene (Usage: take 60mg Raloxifene tablets half an hour
after breakfast every day, that is, take 1 tablet a day), while the second group will receive
clozapine plus oral placebo (Usage: take 1 placebo half an hour after breakfast every day).
Hypothesis 1: Adjuvant raloxifene therapy in postmenopausal women with schizophrenia can
improve negative symptoms, as measured on the rating scales, compared with the women
receiving adjunctive placebo.
Hypothesis 2: The cognitive function of postmenopausal female schizophrenic patients treated
with raloxifene would be better than that of the placebo group.
Hypothesis 3: That the Raloxifene group has less adverse reactions in postmenopausal women
with schizophrenia.