Adjunctive Selective Estrogen Receptor Modulators on Negative and Cognitive Symptoms of Schizophrenia in Women

• Status: Completed
• Trial end date: 2019-07-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Mental Health Center
• Treatments: Estrogen Receptor Modulators; Estrogens; Raloxifene Hydrochloride; Selective Estrogen Receptor Modulators

Criteria

Inclusion Criteria:

1. Outpatient or inpatient, aged more than 45 years, postmenopausal female (menopause for more than one year)

2. International Classification of Diseases, Tenth Revision, diagnosis of schizophrenia

3. Continue to receive antipsychotic clozapine for more than 2 years with a stable dose of at least one month

4. 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%

5. Able to give informed consent

Exclusion Criteria:

1. Participating in other clinical studies

2. Previous use of raloxifene intolerable

3. Hormone related endocrine disease

4. Acute liver disease

5. thrombotic disease

6. Estrogen dependent tumor

7. Hyperthyreosis

8. Severe cardiac dysfunction or renal disease

9. Diabetes mellitus

10. Abnormal uterine bleeding or cerebrovascular accident

11. Hormone replacement therapy

12. using mood stabilizer