A Phase 3 interventional study of raloxifene and placebo in Schizophrenia and Schizoaffective Disorder, sponsored by Sheba Medical Center. Status unknown at 13 sites in 2 countries. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-01-20.
Sponsored by Sheba Medical Center · Phase 3, Interventional, and Treatment
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
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Sheba Medical Center is the lead sponsor of 677 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
Drug: raloxifene
Drug: placebo
raloxifene 60 mg bid
Placebo bid
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
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Raloxifene