Schizophrenia Clinical Trial
— RAPSODIOfficial title:
Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder to Reduce Symptoms and Improve Cognition
Verified date | October 2021 |
Source | UMC Utrecht |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There is increasing clinical and molecular evidence for the role of hormones and specifically estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. The present study will test the extent to which adjunctive raloxifene treatment improved cognition and reduced symptoms in young to middle-age men and women with schizophrenia. 110 patients with a schizophrenia spectrum disorder will be recruited in a multicenter twelve-week, randomized, double-blind, placebo-controlled, parallel trial of adjunctive 120mg raloxifene treatment in addition to their usual antipsychotic medications. The investigators hypothesize that daily treatment with raloxifene 120 milligrams (mg) in addition to antipsychotic treatment improves cognition, reduces psychotic symptoms, increases social and personal functioning and reduces health care costs, as compared to placebo.
Status | Completed |
Enrollment | 110 |
Est. completion date | July 1, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS) - Capable of understanding the purpose and details of the study in order to provide written informed consent; - On a stable dose of antipsychotic medication for at least two weeks; For female patients: - Female patients who are sexually active must be willing and capable to use a non-estrogenic contraceptive (intrauterine device, cervical cap, condom or diaphragm) in case of sexual intercourse for the complete duration of the study; - Female patients with post coital uterine bleeding must have documented normal PAP smear and pelvic examination in the preceding two years. Exclusion Criteria: - Pre-existing cardiovascular disease; - History of thrombo-embolic events; - History of breast cancer; - Familial tendency to form blood clots (such as familial factor V Leiden); - Use of vitamin K antagonists; - Use of cholestyramine or other anion exchange resins; - Hypertriglyceridemia (triglycerides > 3 times the upper limit of normal (ULN)); - Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase (AF), gamma-glutamyl transpeptidase (? - GT), aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 times the ULN as measured at baseline); - Severe kidney failure (eGFR <30 ml/min as measured at baseline); - Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet in the past three months. For female patients: - Abnormality observed during physical breast examination; - Pregnancy or breast feeding; |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
Iris Sommer | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Altrecht GGZ, GGZ Centraal, GGZ Eindhoven, Julius Center, Reinier van Arkel Group, Rudolf Magnus Institute - University of Utrecht, Ziekenhuis Netwerk Antwerpen (ZNA) |
Netherlands,
Heringa SM, Begemann MJ, Goverde AJ, Sommer IE. Sex hormones and oxytocin augmentation strategies in schizophrenia: A quantitative review. Schizophr Res. 2015 Nov;168(3):603-13. doi: 10.1016/j.schres.2015.04.002. Epub 2015 Apr 23. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hormonal biomarkers for predicting treatment response to raloxifene | Hormonal biomarkers (in women: prolactin, follicle stimulating hormone and 17-beta estradiol; in men: prolactin, 17-beta estradiol, testosterone and sex hormone binding globulin and c-reactive protein will be assessed in blood samples to examine whether these parameters predict treatment response to raloxifene augmentation. | Baseline and at 12 weeks of treatment | |
Other | Deoxyribonucleic acid analysis for predicting treatment response to raloxifene | Single nucleotide polymorphism (SNP) analysis of estrogen receptor gene 1 (ESR1) SNP rs2234693, rs9340799, rs2144025 and UGT1A8 gene rs1042597. | Baseline and at 12 weeks of treatment | |
Primary | Change in symptom severity as measured with the Positive and Negative Symptom Scale (PANSS) | Effect of the study therapies on symptom severity. | Baseline, at 6 weeks of treatment, at 12 weeks of treatment (end of treatment) and 6 months after end of treatment (follow-up) | |
Primary | Change in cognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia | Effect of the study therapies on cognitive functioning | Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | |
Secondary | Personal and social performance measured with the Personal and Social Performance scale (PSP) | Effect of the study therapy on personal and social performance. | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | |
Secondary | Thought disorder severity as measured with the Thought And Language Disorder scale (TALD) | Effect of the study therapy on severity of thought disorder. | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | |
Secondary | Participant's Quality of Life as measured with the EQ-5D-5L | Effect of the study therapy on quality of life. | Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | |
Secondary | Comorbid depression as measured with Beck's Depression Inventory (BDI). | Effect of the study therapy on comorbid depression | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | |
Secondary | Use of health-recourses as measured with the iMTA-MCQ | Effect of the study therapy on use of recourses. | Baseline, at 12 weeks (end of treatment) and 6 months follow-up | |
Secondary | Use of non-health recourses as measured with the iMTA-PCQ | Effect of the study therapy on use of recourses. | Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) | |
Secondary | Language production assessment by analyzing speech samples | Effect of the study therapy on free speech. | Baseline and at 12 weeks of treatment (end of treatment) | |
Secondary | Symptom severity as measured with the Brief Negative Symptom Scale (BNSS) | Effect of the study therapies on symptom severity. | Baseline, at 6 weeks, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up) |
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