The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.
Epidemiological evidence shows a potentially protective role for estrogen in women with schizophrenia. The onset of schizophrenia is later in woman than in men, with generally a less severe course until after the menopause, when for many women, reductions in estrogen levels appear to trigger an exacerbation or illness (Hafner 2003). ERα (Estrogen receptor alpha) expression is known to be reduced in schizophrenia (Wong, Woon et al. 2010). Raloxifene is a selective estrogen receptor modulator that acts as an estrogen antagonist in breast tissue and may have agonistic actions in the brain. Several studies (Kulkarni, Riedel et al. 2001; Chua, de Izquierdo et al. 2005; Kulkarni, Gurvich et al. 2010) indicate that treatment with estrogen and raloxifene improves symptoms in females with schizophrenia, and recently they showed an improvement in PANSS score in post menopausal women with schizophrenia receiving 60-120mg/d of raloxifene compared to placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
raloxifene 60 mg bid
Placebo bid
Sheba Medical Center
Ramat Gan, Israel
Clinica de Psihiatrie, Arad
Arad, Romania
Spitalul de Psihiatrie Botosani
Botoșani, Romania
PANSS total score at the end of the trial.
PANSS will be assesed at weeks 5, 8 and end of study.
Time frame: 3 times
PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial.
PANSS will be assessed at week 5, 8, and end of study; CGI-S, CGI-I, will be assessed at week 2, 5, 8, 12, and end of study; BACS will be assessed at week 8 and end of study.
Time frame: PANSS 3 times, CGI-S and CGI-I 5 times and BACS 2 times
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Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest, Romania
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"
Bucharest, Romania
...and 3 more locations