Evidence map›Paper›PMID 37116866›Full record

Trial reportSchizophrenia bulletin2023

The Direct and Long-Term Effects of Raloxifene as Adjunctive Treatment for Schizophrenia-Spectrum Disorders: A Double-Blind, Randomized Clinical Trial.

Bodyl A Brand, Janna N de Boer, Machteld C Marcelis, Koen P Grootens, Jurjen J Luykx, Iris E Sommer

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Schizophrenia bulletin, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
6.0field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
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  4. Research progress in estrogen as an adjunctive therapy for schizophrenia.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Pooled it
  5. Article
  6. The influence of sex on cognition in psychosis.Schizophrenia research. Cognition · 2026
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Bodyl A BrandDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.ORCID 0000-0003-2383-0851
Janna N de BoerDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.ORCID 0000-0003-1231-2733
Machteld C MarcelisDepartment of Psychiatry & Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Koen P GrootensReinier van Arkel Institute for Mental Health Care (RvA), 's Hertogenbosch, The Netherlands.
Jurjen J LuykxDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.
Iris E SommerDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht (UMCU), Utrecht University, Utrecht, The Netherlands.
University Medical Center Groningen · NLMaastricht University · NLTilburg University · NLUtrecht University · NL

Funding

Dutch Organization for Health and Research Development 80-83600-98-40120Rational Pharmacotherapy 836041008
6 · The paper itself

Abstract

background and hypothesisSeveral studies suggest that raloxifene, a selective estrogen receptor modulator, improves symptoms and cognition in post-menopausal women with Schizophrenia-Spectrum Disorders (SSD). We aimed to assess the effects of adjunctive raloxifene in women and men with SSD. STUDY

designThis parallel, randomized, double-blind, placebo-controlled trial included adult SSD patients across the Netherlands and Belgium. Participants were stratified by age, sex, and global functioning and randomly assigned 1:1 to 12-week add-on raloxifene or placebo. Primary outcomes were symptom severity at 6, 12, and 38 weeks and cognition at 12 and 38 weeks, as measured with the Positive and Negative Syndrome Scale and the Brief Assessment of Cognition in Schizophrenia, respectively. Intention-to-treat analyses were performed using linear mixed-effect models. STUDY

resultsWe assessed 261 patients for eligibility, of which 102 (28% female) were assigned to raloxifene (n = 52) or placebo (n = 48). Although we found no main effect of raloxifene, secondary sex-specific analysis showed that in women, raloxifene had beneficial effects on negative symptoms at week 6 (LSM -2.92; adjusted P = 0.020) and week 12 (LSM -3.12; adjusted P = 0.030), and on working memory at week 38 (LSM 0.73; adjusted P = 0.040), while having negative effects on working memory at week 38 in men (LSM -0.53; adjusted P = 0.026). The number of adverse events was similar between groups.

conclusionsOur results do not support the use of raloxifene in patients with SSD in general, but suggest female-specific beneficial effects of raloxifene on negative symptoms and working memory. Our findings encourage further research on sex-specific pharmacotherapeutic treatment.

Indexed as

Antipsychotic AgentsSchizophreniaAdultDouble-Blind MethodFemaleHumansInfant, NewbornMalePostmenopauseRaloxifene HydrochlorideSelective Estrogen Receptor ModulatorsTreatment OutcomeAntipsychotic AgentsRaloxifene HydrochlorideSelective Estrogen Receptor Modulatorsantipsychotic medicationestrogenraloxifeneRCTschizophreniaSERMsex differences

Identifiers

PMID37116866
PMCPMC10686337
OpenAlexW4367302231

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.