SchizophreniaPhase 4NCT01041092
Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women
A Phase 4 study testing raloxifene in people with Schizophrenia, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women. This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- raloxifene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2004to Dec 2009
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia (DSM-IV criteria)
- Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level > 20IU/L.
- Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
- Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
- Patients have to give written informed consent to participate in the study.
Who cannot join
- Patients with a substance abuse/dependence diagnosis in the previous six months.
- Mental retardation.
- Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
- History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
- Patients taking hormone replacement therapy.
- Patients taking mood stabilizer medication that cannot be discontinued.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Placebo-controlled Study of Efficacy, Safety and Tolerance of Raloxifene as an Adjuvant Treatment for Negative Symptoms of Schizophrenia in Postmenopausal Women
Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women.
This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Treatment period of 12 weeks.
The primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. The investigators also found improved response in some aspects of social functioning and neuropsychological functioning.
- Conditions
- Schizophrenia
- Being tested
- raloxifene
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raloxifeneDrug
Dose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | Not described Receives: Drug: raloxifene |
| raloxifene hydrochloride | Active comparator | Dose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks. Receives: Drug: raloxifene |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
Secondary outcomes (1)
Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startJun 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041092
- Sponsor's protocol ID
- 04T-504
- Status last verified
- Dec 2009
- First submitted
- 30 Dec 2009
- Last updated
- 31 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huerta-Ramos E, Iniesta R, Ochoa S, Cobo J, Miquel E, Roca M, Serrano-Blanco A, Teba F, Usall J. Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. Eur Neuropsychopharmacol. 2014 Feb;24(2):223-31. doi: 10.1016/j.euroneuro.2013.11.012. Epub 2013 Dec 1.
PubMed 24342775Usall J, Huerta-Ramos E, Iniesta R, Cobo J, Araya S, Roca M, Serrano-Blanco A, Teba F, Ochoa S. Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Nov;72(11):1552-7. doi: 10.4088/JCP.10m06610. Epub 2011 Aug 23.
PubMed 21903021
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Placebo-controlled Study of Efficacy, Safety and Tolerance of Raloxifene as an Adjuvant Treatment for Negative Symptoms of Schizophrenia in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01041092
- Acronym / sponsor ID
- 04T-504
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Dec 2009 (estimated)
- 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.
Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women.
This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Treatment period of 12 weeks.
The primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. The investigators also found improved response in some aspects of social functioning and neuropsychological functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Drug: raloxifene |
| raloxifene hydrochloride | Active comparator | Drug: raloxifeneDose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia (DSM-IV criteria)
- Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level > 20IU/L.
- Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
- Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
- Patients have to give written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Patients with a substance abuse/dependence diagnosis in the previous six months.
- Mental retardation.
- Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
- History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
- Patients taking hormone replacement therapy.
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 |
|---|---|---|
| raloxifeneDose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks. | Drug | raloxifene hydrochloride, sugar pill |
Primary outcome
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.
1 secondary outcome
Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.
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 31 Dec 2009.
- Derived from this study: PubMed 24342775Huerta-Ramos E, Iniesta R, Ochoa S, Cobo J, Miquel E, Roca M, Serrano-Blanco A, Teba F, Usall J. Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. Eur Neuropsychopharmacol. 2014 Feb;24(2):223-31. doi: 10.1016/j.euroneuro.2013.11.012. Epub 2013 Dec 1.
- Derived from this study: PubMed 21903021Usall J, Huerta-Ramos E, Iniesta R, Cobo J, Araya S, Roca M, Serrano-Blanco A, Teba F, Ochoa S. Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Nov;72(11):1552-7. doi: 10.4088/JCP.10m06610. Epub 2011 Aug 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Schizophrenia, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 6 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 31 Dec 2009. 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 Spain. 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?
The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01041092, which also lists 2 linked publications.
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 31 Dec 2009.