Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder (NCT03043820) | Clinical Trial Compass
CompletedPhase 3
Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder
Netherlands110 participantsStarted 2016-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (γ - 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 inc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in symptom severity as measured with the Positive and Negative Symptom Scale (PANSS)
Timeframe: Baseline, at 6 weeks of treatment, at 12 weeks of treatment (end of treatment) and 6 months after end of treatment (follow-up)
2
Change in cognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia
Timeframe: Baseline, at 12 weeks (end of treatment) and 6 months after end of treatment (follow-up)