Status:
COMPLETED
Adjunctive Selective Estrogen Receptor Modulators on Negative and Cognitive Symptoms of Schizophrenia in Women
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Schizophrenia
Eligibility:
FEMALE
45+ years
Phase:
PHASE4
Brief 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 pos...
Detailed Description
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, negati...
Eligibility Criteria
Inclusion
- Outpatient or inpatient, aged more than 45 years, postmenopausal female (menopause for more than one year)
- International Classification of Diseases, Tenth Revision, diagnosis of schizophrenia
- Continue to receive antipsychotic clozapine for more than 2 years with a stable dose of at least one month
- Negative symptoms scale \>20 in PANSS, and a score of 4 (moderate) or more on one or more of N1-N7, and within two weeks before intervention, the total score of negative symptom factors improved by no more than 10%
- Able to give informed consent
Exclusion
- Participating in other clinical studies
- Previous use of raloxifene intolerable
- Hormone related endocrine disease
- Acute liver disease
- thrombotic disease
- Estrogen dependent tumor
- Hyperthyreosis
- Severe cardiac dysfunction or renal disease
- Diabetes mellitus
- Abnormal uterine bleeding or cerebrovascular accident
- Hormone replacement therapy
- using mood stabilizer
Key Trial Info
Start Date :
July 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03418831
Start Date
July 17 2018
End Date
July 30 2019
Last Update
September 6 2019
Active Locations (1)
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1
CHINA
Shanghai, Minhang, China, 201108