Evaluating Bazedoxifene as an Add-On Treatment in Women With Schizophrenia A Double-Blind, Placebo-Controlled Phase 4 Study

What this Trial Is About

Researchers are studying the effects of bazedoxifene, a selective estrogen receptor modulator SERM, as an additional treatment for women with schizophrenia. This trial focuses on women aged 18 to 65 who have a diagnosis of schizophrenia or related disorders. The study aims to evaluate whether bazedoxifene can improve psychosis symptoms and cognitive function, building on prior research suggesting hormone modulators may impact schizophrenia treatment. The trial is double-blind, randomized, and placebo-controlled to assess the treatments effects accurately. Participants will receive either oral bazedoxifene at a dose of 40 mg daily or an identical placebo pill for 12 weeks, alongside their regular antipsychotic medication. The study compares these two groups to determine the impact of bazedoxifene on schizophrenia symptoms and cognition. The trials design includes careful monitoring and blinding to ensure unbiased results. During the 12-week treatment period, participants will undergo assessments of schizophrenia symptoms using standardized scales and cognitive tests. Researchers will monitor participants health, including breast and pelvic examinations for safety, and track any changes in psychotropic medication or therapy. The primary outcome is symptom improvement at 12 weeks, with secondary measures focusing on cognitive changes. Participation includes informed consent and adherence to scheduled visits and tests throughout the study.

Bazedoxifene -Treatment for Women With Schizophrenia