Evidence map›Paper›PMID 26591005›Full record

Trial reportSchizophrenia bulletin2016

Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial.

Judith Usall, Elena Huerta-Ramos, Javier Labad, Jesús Cobo, Christian Núñez, Marta Creus, Gemma García Parés, Daniel Cuadras, José Franco, Eva Miquel and 3 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Schizophrenia bulletin, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01573637 (Six Month, Double Blind, Placebo-controlled Trial of the Efficacy of Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women), which is not on this map. Cited by 29 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 6 pooled it
7.2field-weighted citation impact, top 2% 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.

NCT01573637 phase3completednot on this map

Six Month, Double Blind, Placebo-controlled Trial of the Efficacy of Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women

TypeinterventionalSponsorFundació Sant Joan de DéuRan2011 to 2014Enrolled78ConditionsSchizophrenia in Post Menopausal WomenArmsRaloxifene, Lactosa (placebo arm)
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 6 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Article
  12. Article
  13. Review
  14. Estrogen and psychosis - a review and future directions.Archives of women's mental health · 2024
    Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Gaps or links between hormonal therapy and schizophrenia? (Review).Experimental and therapeutic medicine · 2020
    Review
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

13 authors at 5 institutions in 2 countries.

Judith Usalljusall@pssjd.org.
Elena Huerta-Ramos
Javier Labad
Jesús CoboCatalan Group in Women's Mental Health Research (GTRDSM), Barcelona, Spain; Corporació Sanitària i Universitària Parc Taulí, Psychiatry Department, Sabadell, Spain;
Christian NúñezParc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
Marta CreusHospital Universitari Institut Pere Mata, IISPV, Universitat Rovira i Virgili, Psychiatry Department, Reus, Spain;
Gemma García ParésCatalan Group in Women's Mental Health Research (GTRDSM), Barcelona, Spain; Corporació Sanitària i Universitària Parc Taulí, Psychiatry Department, Sabadell, Spain; CAP EAE SALUT MENTAL, Andorra.
Daniel CuadrasParc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
José FrancoInstituto de Salud Carlos III, Centro de Investigación en Red de Salud Mental (CIBERSAM), Madrid, Spain; Hospital Universitari Institut Pere Mata, IISPV, Universitat Rovira i Virgili, Psychiatry Department, Reus, Spain;
Eva MiquelParc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
Julio César ReyesInstituto de Salud Carlos III, Centro de Investigación en Red de Salud Mental (CIBERSAM), Madrid, Spain; Hospital Universitari Institut Pere Mata, IISPV, Universitat Rovira i Virgili, Psychiatry Department, Reus, Spain;
Mercedes RocaParc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
RALOPSYCAT Group
Parc Sanitari Sant Joan de Déu · ESUniversidad Rovira i Virgili · ESCorporació Sanitària Parc Taulí · ESInstitut d'Investigació Sanitària Pere Virgili · ESUniversity of Andorra · AD

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledThe potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to estrogens on dopamine and serotonin brain systems. One previous trial by our team found that raloxifene was useful to improve negative, positive, and general psychopathological symptoms, without having the negative side effects of estrogens. In this study, we assess the utility of raloxifene in treating negative and other psychotic symptoms in postmenopausal women with schizophrenia exhibiting prominent negative symptoms. This was a 24-week, randomized, parallel, double-blind, placebo-controlled study. Patients were recruited from the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy postmenopausal women with schizophrenia (DSM-IV) were randomized to either adjunctive raloxifene (38 women) or adjunctive placebo (32 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS). The addition of raloxifene (60 mg/d) to regular antipsychotic treatment significantly reduced negative (P = .027), general (P = .003), and total symptomatology (P = .005) measured with the PANSS during the 24-week trial, as compared to women receiving placebo. Also Alogia SANSS subscale improved more in the raloxifene (P = .048) than the placebo group. In conclusion, raloxifene improved negative and general psychopathological symptoms, compared with antipsychotic medication alone, in postmenopausal women with schizophrenia. These data replicate our previous results with a larger sample and a longer follow-up.

trial registrationNCT01573637.

Indexed as

Outcome Assessment, Health CarePostmenopauseAgedAntipsychotic AgentsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMiddle AgedPlacebosRaloxifene HydrochlorideSchizophreniaSelective Estrogen Receptor ModulatorsAntipsychotic AgentsPlacebosRaloxifene HydrochlorideSelective Estrogen Receptor Modulatorsestrogennegative symptomsSERM

Identifiers

PMID26591005
PMCPMC4753610
OpenAlexW2181050850

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.