Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder
Status:
Completed
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Iris Sommer
Collaborators:
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 Rudolf Magnus Institute – University of Utrecht Ziekenhuis Netwerk Antwerpen (ZNA)