Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a 24-week double-blind, randomized, parallel, placebo-controlled trial

Abstract

We assessed the utility of raloxifene (60 mg/day) as an adjuvant treatment for cognitive symptoms in postmenopausal women with schizophrenia in a 24-week, double-blind, randomized, placebo-controlled study. Patients were recruited from the inpatient and outpatient services of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy eight postmenopausal women with schizophrenia were randomized to either adjunctive raloxifene or placebo. Sixty-eight began the clinical trial (37 women on raloxifene adjunct) and 31 on placebo adjunct. The outcome measures were: memory, attention and executive function. Assessment was conducted at baseline and at week 24. Between groups homogeneity was tested with the Student's t test for continuous variables and/or the Mann–Whitney U test for ordinal variables and the χ2 test or Fisher's exact test for categorical variables. The differences between the two groups in neuropsychological test scores were compared using the Student's t test. The sample was homogenous with respect to age, formal education, illness duration and previous pharmacological treatment. The addition of raloxifene to antipsychotic treatment as usual showed no differences in cognitive function. The daily use of 60 mg raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia has no appreciable effect.

ClinicalTrials.gov Identifier: NCT01573637.

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Acknowledgements

The Stanley Medical Research Institute (#10T-1392). The members of RALOPSYCAT Group are Carolina Rodríguez (nurse), Isabel Beneitez (psychiatrist), Joan Costa (clinician), Lourdes Castro (nurse), Silvia Teba (nurse), Laura Milian (nurse), Alexandrina Foix (nurse), Sonia Rivero (psychiatrist), Marian Cavero (psychiatrist), María Argemí (psychiatrist), Fernando Teba (psychiatrist), Belén Arranz (psychiatrist), Elena Rubio (psychiatrist), Marta Coromina (psychiatrist), Ángeles Santos (nurse), Jose Luis Bogas (nurse), Ana Barber (nurse), Carlota Romans (psychiatrist), Manel Márquez (psychiatrist), Anna Sabata (nurse), Lourdes Nieto (psychologist), Eva Willikens (psychologist), Enrich Blanch (nurse), Siddharta Acebillo (psychiatrist), Ramón Coronas (psychiatrist), Laura Ortega (nurse), Ignasi Coll (psychiatrist), Joaquín Valero (psychiatrist), Jesús Rodríguez (psychiatrist), Modesto Pérez (psychiatrist), Inés Niubó (psychiatrist), Montse Tost (psychologist), Mari Pau Monfort (pharmacist), Lourdes Martorell (biologist), Elisabet Vilella (biologist), Judith Usall (psychiatrist), Elena Huerta-Ramos (psychologist), Javier Labad (psychiatrist), Jesús Cobo (psychiatrist), Christian Núñez (psychologist), Marta Creus (psychologist), Gemma García-Parés (psychiatrist), Daniel Cuadras (statistical), José Franco (psychiatrist), Eva Miquel (pharmacist), Julio-César Reyes (psychiatrist), Mercedes Roca (psychiatrist).

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Correspondence to Elena Huerta-Ramos.

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Huerta-Ramos, E., Labad, J., Cobo, J. et al. Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a 24-week double-blind, randomized, parallel, placebo-controlled trial. Eur Arch Psychiatry Clin Neurosci 270, 729–737 (2020). https://doi.org/10.1007/s00406-019-01079-w

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Keywords

  • Raloxifene
  • Schizophrenia
  • Cognition
  • Clinical trial