SchizophreniaPhase 4NCT03418831
Adjunctive Selective Estrogen Receptor Modulators on Negative and Cognitive Symptoms of Schizophrenia in Women
A Phase 4 study testing Raloxifene Hydrochloride in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Raloxifene Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2018to 30 Jul 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participating in other clinical studies
- Previous use of raloxifene intolerable
- Hormone related endocrine disease
- Acute liver disease
- thrombotic disease
- Estrogen dependent tumor
Show all 12Show fewer
- Hyperthyreosis
- Severe cardiac dysfunction or renal disease
- Diabetes mellitus
- Abnormal uterine bleeding or cerebrovascular accident
- Hormone replacement therapy
- using mood stabilizer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Estrogen Receptor Modulators - Adjunctive Treatment for Negative and Cognitive Symptoms of Schizophrenia in Postmenopausal Women
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).
Read more
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.
Read the 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, 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.
- Conditions
- Schizophrenia
- Being tested
- Raloxifene Hydrochloride, Placebo
- Keywords
- negtive symptoms, cognitive function
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raloxifene HydrochlorideDrug
Also called Evista
60 mg per capsule (1 tablet daily) for 12 weeks
PlaceboOther
Also called Starch capsule
1 tablet daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Raloxifene | Active comparator | Raloxifene Hydrochloride Receives: Drug: Raloxifene Hydrochloride |
| Placebo | Placebo comparator | placebo tablet Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response in negative symptoms
A response in negative symptoms was defined as improvement of ≥20% compared with baseline PANSS negative score (12 weeks)
Measured: baseline, week 4, 8, 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: baseline, week 12
Hormone level change
Hormone level change over study duration (12 weeks)
Measured: baseline, week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start17 Jul 2018
- Primary completion30 Apr 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LV QINYU, Principal investigator, SHANGHAI MENTAL HEALTH CENTRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418831
- Sponsor's protocol ID
- 2017-YJ-01
- Status last verified
- Feb 2019
- First submitted
- 22 Jan 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Estrogen Receptor Modulators - Adjunctive Treatment for Negative and Cognitive Symptoms of Schizophrenia in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT03418831
- Acronym / sponsor ID
- 2017-YJ-01
- Conditions
- Schizophrenia
- Keywords
- negtive symptoms, cognitive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raloxifene | Active comparator | Drug: Raloxifene HydrochlorideRaloxifene Hydrochloride |
| Placebo | Placebo comparator | Other: Placeboplacebo tablet |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Participating in other clinical studies
- Previous use of raloxifene intolerable
- Hormone related endocrine disease
- Acute liver disease
- thrombotic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raloxifene HydrochlorideAlso: Evista60 mg per capsule (1 tablet daily) for 12 weeks | Drug | Raloxifene |
| PlaceboAlso: Starch capsule1 tablet daily for 12 weeks | Other | Placebo |
Primary outcome
Response in negative symptoms
Time frame: baseline, week 4, 8, 12
A response in negative symptoms was defined as improvement of ≥20% compared with baseline PANSS negative score (12 weeks)
4 secondary outcomes
Clinical Assessment Interview for Negative Symptoms(CAINS)
Time frame: baseline, week 4, 8, 12
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: baseline, week 4, 8, 12
Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
Time frame: baseline, week 12
Hormone level change
Time frame: baseline, week 4, 8, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LV QINYU principal investigator
SHANGHAI MENTAL HEALTH CENTRE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raloxifene Hydrochloride in people with Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response in negative symptoms (time frame: baseline, week 4, 8, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.