Raloxifene Augmentation in Patients With a Schizophrenia Spectrum Disorder

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder
• Psychosis NOS

Interventions

DRUG

Raloxifene

Oral selective estrogen receptor modulator (SERM).

DRUG

Placebo

Tablets identical in form and color to intervention.

Sponsors & Collaborators

• Julius Center

  collaborator OTHER

• Rudolf Magnus Institute - University of Utrecht

  collaborator OTHER

• GGZ Eindhoven

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• GGZ Centraal

  collaborator OTHER

• Altrecht GGZ

  collaborator UNKNOWN

• Reinier van Arkel Group

  collaborator UNKNOWN

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Iris Sommer

  lead OTHER

Principal Investigators

• Iris Sommer, Prof. dr. · UMC Groningen

• Bob Oranje, Ass. Prof. · UMC Utrecht

• Janna de Boer, MD · UMC Utrecht

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2021-07-01

Completion

2021-07-01

Countries

• Netherlands

Study Locations