A Phase 4 interventional study of Raloxifene Hydrochloride and Placebo in Schizophrenia, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Shanghai Mental Health Center · Phase 4, Interventional, and Treatment
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.
Schizophrenia is a mental illness with unknown cause and difficult treatment which the global lifetime prevalence rate of about 1%. The core symptoms of schizophrenia include positive symptoms, negative symptoms, and impairment of cognitive function. Positive symptoms in most patients after antipsychotic treatment can significantly alleviate after antipsychotic treatment, but negative symptoms and cognitive deficits persist. Unfortunately, the long-term prognosis and social function of patients mainly depend on the degree of the rehabilitation of negative symptoms and cognitive function. At present, clinical research domestic and overseas on the negative symptoms and cognitive function gradually increased, but end up with the poor consistency of research results. The reason is various, but in any case, improving the treatment strategy is still very important.
Epidemiological data suggest that the age of onset of female schizophrenia is later than men, most of which are onset abruptly, and females have higher susceptibility to mental illness and relapse during the two important periods with hormonal changes. The first is in the postpartum, menopause is the second. It may be related to the lack of estrogen function. Therefore, we believe that the onset and symptoms of some female patients with schizophrenia are related to the dysfunction of estrogen. Many studies abroad have found that estrogen and selective estrogen receptor modulators have significant effects on female patients with schizophrenia, especially on negative symptoms and cognitive functions, but the clinical application is limited due to the potential side effects of estrogen.
Raloxifene is the second generation of selective estrogen receptor modulator, for the prevention and treatment of osteoporosis in postmenopausal women, which can significantly reduce the incidence of vertebral fractures. The common adverse drug reaction is slight increase in hot flash and leg cramps, and the most serious adverse drug reaction is venous thromboembolism. Past research has found that raloxifene can reduce the risk of decline in memory and attention, and taking raloxifene helps sleep. Current research suggests that as an adjuvant therapy, it can improve symptoms of menopausal women with schizophrenia (emotional symptoms, memory, information processing and storage), and will not negatively affect reproductive tissues or organs, such as breast, uterus and ovary.
According to the domestic and overseas research results, and based on the theoretical background of schizophrenia in estrogen insufficiency, we proposed randomized double-blind placebo-controlled study, in order to understand the effect of raloxifene on negative symptoms and cognitive function in adjuvant treatment of menopausal female patients with schizophrenia, meanwhile assess the adverse reactions after the treatment, provide the basis for clinical treatment of schizophrenia patients with negative symptoms and cognitive impairment.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 45 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Raloxifene Hydrochloride
Drug: Raloxifene Hydrochloride
placebo tablet
Other: Placebo
60 mg per capsule (1 tablet daily) for 12 weeks
Also known as: Evista
1 tablet daily for 12 weeks
Also known as: Starch capsule
Response in negative symptoms
A response in negative symptoms was defined as improvement of ≥20% compared with baseline PANSS negative score (12 weeks)
Time frame: baseline, week 4, 8, 12
Clinical Assessment Interview for Negative Symptoms(CAINS)
The CAINS is a scale of the clinical assessment interview for negative symptoms of schizophrenia.The CAINS includes 16 items covering motivation and pleasure across social (five items), vocational (three items), and recreational life (three items) domains, as well as emotion expression and speech (five items).All items were rated on a scale of 0-4, with higher scores reflecting greater impairment.
Time frame: baseline, week 4, 8, 12
Scale for the Assessment of Negative Symptoms (SANS)
The SANS are the most widely used symptom rating scales in schizophrenia research. SANS Total (Composite) score = sum(of SANS items 1-7, 9-12, 14-16, 18-21, and 23-24).The total range is from 0-120 scores.
Time frame: baseline, week 4, 8, 12
Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
The RBANS is a brief cognitive screening battery consisting of 12 subtests which are used to create Index scores in the following five cognitive domains: Immediate Memory, Visuospatial/Constructional Skills, Language, Attention, and Delayed Memory. A total score is created by summing the five index cores which are thought to represent one's current neuropsychological status.
Time frame: baseline, week 12
Hormone level change
Hormone level change over study duration (12 weeks)
Time frame: baseline, week 4, 8, 12
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Apr 2019, 9 months.
Of 71 non-industry phase 4 interventional studies under Schizophrenia, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 64. This study's 9 months is below that.
Counting every sponsor, half of 88 studies reached it within 39 months; a quarter within 20 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Raloxifene
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