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

NCT03418831 | Completed Phase 4

• 1 other identifier: 2017-YJ-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Schizophrenia

Keywords

negtive symptoms; cognitive function

Outcome Measures

Primary Outcomes (1)

• Response in negative symptoms

  A response in negative symptoms was defined as improvement of ≥20% compared with baseline PANSS negative score (12 weeks)

  baseline, week 4, 8, 12

Secondary Outcomes (4)

• Clinical Assessment Interview for Negative Symptoms(CAINS)

  baseline, week 4, 8, 12

• Scale for the Assessment of Negative Symptoms (SANS)

  baseline, week 4, 8, 12

• Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)

  baseline, week 12

• Hormone level change

  baseline, week 4, 8, 12

Study Arms (2)

Raloxifene

ACTIVE COMPARATOR

Raloxifene Hydrochloride

Drug: Raloxifene Hydrochloride

Placebo

PLACEBO COMPARATOR

placebo tablet

Other: Placebo

Interventions

Raloxifene Hydrochloride DRUG

60 mg per capsule (1 tablet daily) for 12 weeks

Also known as: Evista

Raloxifene

Placebo OTHER

1 tablet daily for 12 weeks

Also known as: Starch capsule

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

CHINA

Shanghai, Minhang, 201108, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Raloxifene Hydrochloride; Starch

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• LV QINYU

  SHANGHAI MENTAL HEALTH CENTRE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 1, 2018
• Study Start: July 17, 2018
• Primary Completion: April 30, 2019
• Study Completion: July 30, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-02

Locations

CN (1)