Trial record 11 of 2064 for:
schizophrenia
Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women
This study is currently recruiting participants.
Verified February 2013 by Fundació Sant Joan de Déu
Sponsor:
Fundació Sant Joan de Déu
Collaborators:
Hospital Sant Joan de Deu
Parc Sanitari Sant Joan de Déu
Stanley Medical Research Institute
Information provided by (Responsible Party):
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT01573637
First received: April 5, 2012
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
The efficacy of raloxifene versus placebo was compared over a six-month period, as an adjuvant treatment of the negative symptoms of schizophrenia in a group of 80 post-menopausal women. The aim of the study is to analyze whether raloxifene has an effect on the positive and negative symptoms of schizophrenia, and on psychopathological symptoms in general, and on social and neuropsychological functioning, and to study the influence of genetic polymorphisms in treatment response.
| Condition | Intervention | Phase |
|---|---|---|
|
Negative Symptoms of Schizophrenia in Post-menopausal Women. |
Drug: Raloxifene Drug: Lactosa (placebo arm) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Six Month, Double Blind, Placebo-controlled Trial of the Efficacy of Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women |
Resource links provided by NLM:
Further study details as provided by Fundació Sant Joan de Déu:
Primary Outcome Measures:
- To assess the efficacy of raloxifene (SERM - Selective Estrogen Receptor Modulator) as an adjuvant of antipsychotic treatment in the management of negative symptoms of schizophrenia in post-menopausal women. [ Time Frame: Change in score on the negative subscale of the PANSS from baseline to final assessment at week 24 ] [ Designated as safety issue: Yes ]The primary variable of efficacy will correspond to the change in score on the negative subscale of the PANSS from the start of treatment to the final assessment at 24 weeks. Patients will be considered to respond to treatment if the score in the negative subscale is at least 20% lower than at the start of treatment.
Secondary Outcome Measures:
- To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the management of global symptoms of schizophrenia in postmenopausal women. [ Time Frame: From baseline to week 24 (measurements at Baseline, weeks 4, 12, 24) ] [ Designated as safety issue: No ]The results from different scales or test will be measured: at baseline,week 4,12 y 24 for scales (PANSS, SANS, CGI, GAF, CDSS -Calgary, LSP, SIMPSON, UKU, DAS-sv) and at baseline, week 12 and 24 for neuropsychological test (TAVEC, CPT, TMT, STROOP, FAS, WAIS sub-tests).
- To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the global functioning of postmenopausal women with schizophrenia. [ Time Frame: From baseline to week 24 (measurements at Baseline, weeks 4, 12, 24) ] [ Designated as safety issue: No ]The results from different scales or test will be measured: at baseline,week 4,12 y 24 for scales (PANSS, SANS, CGI, GAF, CDSS -Calgary, LSP, SIMPSON, UKU, DAS-sv) and at baseline, week 12 and 24 for neuropsychological test (TAVEC, CPT, TMT, STROOP, FAS, WAIS sub-tests).
- To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the neuropsychological functioning of post-menopausal women with schizophrenia [ Time Frame: From baseline to week 24 (measurements at Baseline, week 12, week 24) ] [ Designated as safety issue: No ]The results from different test will be measured at weeks, baseline, 12 and 24 for neuropsychological test (TAVEC, CPT, TMT, STROOP, FAS, WAIS sub-tests).
- To control response to treatment as a function of genetic variants in the form of SNP (Single Nucleotide Polymorphisms) that patients present in the alfa (ESR1) and beta (ESR2) estrogenic receptor genes. [ Time Frame: Blood sample collected at Baseline visit ] [ Designated as safety issue: No ]Analysis will be done for patients who consented by the Informed Consent Form. The analysis will be carried out by centralized laboratory (Biobanc Institut d´Investigació Sanitària Pere Virgili; Reus, Spain) once all samples will be collected. In the meantime, the samples will be kept frozen at 4oC.
- To assess the safety of the medication used in this patient population. [ Time Frame: From Baseline to week 24 ] [ Designated as safety issue: Yes ]Safety will be assessed during the study by the vigilance of the AEs, SAEs, AR, SARs at each visit. Blood analysis (hemo/chem) will be done at Baseline and at the end (week 24), and clinical scales will be measured at Baseline, week 4,12 y 24 (PANSS, SANS, CGI, GAF, CDSS -Calgary, LSP, SIMPSON, UKU, DAS-sv)
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Raloxifene hydrochloride 60 mg
Patients fulfilling inclusion criteria and those giving the general informed consent for the study will be randomly allocated to one of the two groups in the trial (placebo or raloxifene) in a 1:1 proportion and in blocks of 4 patients, using the random number tables designed for this purpose. The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Both drugs will be given orally in capsule form. The medication of each of the treatment groups (lactose as placebo, raloxifene) will be introduced into dark green gelatin capsules to guarantee the blinding. |
Drug: Raloxifene
The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.
Other Name: Raloxifene hydrochloride 60 mg, Laboratory Esteve.
|
|
Placebo Comparator: Lactosa (placebo)
Patients fulfilling inclusion criteria and those giving the general informed consent for the study will be randomly allocated to one of the two groups in the trial (placebo or raloxifene) in a 1:1 proportion and in blocks of 4 patients, using the random number tables designed for this purpose. The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Both drugs will be given orally in capsule form. The medication of each of the treatment groups (lactose as placebo, raloxifene) will be introduced into dark green gelatin capsules to guarantee the blinding. |
Drug: Lactosa (placebo arm)
Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.
Other Name: Lactosa
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Diagnosis of schizophrenia according to DSM-IV TR criteria.
- Postmenopausal patients. Post-menopausal is defined as 1) aged over 45 years with at least one year of amenorrhea and levels of FSH over 20 UI/L or 2) aged over 50 years with at least one year of amenorrhea.
- Patients who have been taking a stable dose of antispsychotic medication for at least the 30 days before the start of the study.
- The presence of significant negative symptoms (defined as one or more negative symptoms with a severity of over 4 on the PANSS scale).
- General written informed consent by patients or their legal representative.
- For the genotypic study, a specific informed consent signed by the patients or legal representative is required.
Exclusion criteria:
- A diagnosis of substance abuse/dependence in the previous 6 months.
- Mental retardation
- A diagnosis of major depression (according to DSM-IV TR criteria).
- Endocrine alterations related to sexual hormones, liver insufficiency including cholestasis, severe renal insufficiency.
- History or current condition of thromboembolism, breast cancer, abnormal uterine bleeding or stroke.
- Patients in hormone replacement therapy.
- Known allergy or hypersensitivity to the active ingredient of the investigational drug, or to any of its excipients or lactose.
- To be receiving treatment in another clinical trial.
- To present any severe concomitant disease that in the researcher's opinion can compromise completion of the study or affect the patient's tolerance to this treatment.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573637
Contacts
| Contact: Judith Usall, MD PhD | +34 93 640 63 50 ext 2347 | jusall@pssjd.org |
Locations
| Spain | |
| Corporació Sanitària Parc Taulí | Recruiting |
| Sabadell, Barcelona, Spain, 08208 | |
| Contact: Gemma Garcia-Parés, MD PdD +34 610 23 07 13 GGarcia@tauli.cat | |
| Contact: Jesús Vicente Cobo, Psychiatrist +34 610 23 07 20 JCobo@tauli.cat | |
| Principal Investigator: Gemma Garcia-Parés, Psychiatrist | |
| Sub-Investigator: Jesús Vicente Cobo, Psychiatrist | |
| Sub-Investigator: Lourdes Nieto, Psichologist | |
| Parc Sanitari Sant Joan de Déu | Recruiting |
| Sant Boi de Llobregat, Barcelona, Spain, 08830 | |
| Contact: Judith Usall, MD PhD +34 93 640 63 50 ext 2347 jusall@pssjd.org | |
| Contact: María Elena Huerta, Psychologist +34 93 640 63 50 ext 2347 mehuerta@pssjd.org | |
| Principal Investigator: Judith Usall, PhD | |
| Sub-Investigator: María Elena Huerta, Psychologist | |
| Sub-Investigator: Marta Coromina, Psychologist | |
| Sub-Investigator: Belén Arranz, Psychiatrist | |
| Sub-Investigator: Mercedes Roca, Psychiatrist | |
| Sub-Investigator: Susana Ochoa, Psychologist | |
| Hospital Psiquiàtric Institut Pere Mata | Recruiting |
| Reus, Tarragona, Spain, 43206 | |
| Contact: Javier Labad, Dr +34 977 333 85 65 ext 395 labadj@gmail.com | |
| Contact: Marta Creus, Psychologist +34 977 333 85 65 ext 395 creusm@peremata.com | |
| Principal Investigator: Javier Labad, Psychiatrist | |
| Sub-Investigator: Marta Creus, Psychologist | |
| Sub-Investigator: José Franco, Psychiatrist | |
| Sub-Investigator: Julio César Reyes, Psychiatrist | |
| Sub-Investigator: Lourdes Martorell, Geneticist | |
Sponsors and Collaborators
Fundació Sant Joan de Déu
Hospital Sant Joan de Deu
Parc Sanitari Sant Joan de Déu
Stanley Medical Research Institute
Investigators
| Principal Investigator: | Judith Usall, PhMD | Parc Sanitari Sant Joan de Déu |
| Principal Investigator: | Javier Labad Arias, PhMD | Hospital Psiquiàtric Institut Pere Mata de Reus |
| Principal Investigator: | Gemma García-Parés, PhMD | Corporació Sanitária Parc Taulí |
More Information
Additional Information:
Publications:
| Responsible Party: | Fundació Sant Joan de Déu |
| ClinicalTrials.gov Identifier: | NCT01573637 History of Changes |
| Other Study ID Numbers: | FSJD-RAL-2010 |
| Study First Received: | April 5, 2012 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Fundació Sant Joan de Déu:
|
schizophrenia negative schizophrenia schizophrenia in post-menopausal women schizophrenia in women negative symptoms of schizophrenia negative symptoms in schizophrenia |
schizophrenia symptoms ralixifene raloxifen raloxifeno negative symptoms of psychosis |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Raloxifene Selective Estrogen Receptor Modulators Estrogen Receptor Modulators |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on June 18, 2013