Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women

NCT01573637 | Completed Phase 3

• 1 other identifier: FSJD-RAL-2010
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 3

Brief Summary

The efficacy of raloxifene versus placebo was compared over a six-month period, as an adjuvant treatment of the negative symptoms of schizophrenia in a group of 80 post-menopausal women. The aim of the study is to analyze whether raloxifene has an effect on the positive and negative symptoms of schizophrenia, and on psychopathological symptoms in general, and on social and neuropsychological functioning, and to study the influence of genetic polymorphisms in treatment response.

Conditions

Schizophrenia in Post Menopausal Women

Keywords

schizophrenia; negative schizophrenia; schizophrenia in post-menopausal women; schizophrenia in women; ralixifene; raloxifen; raloxifeno; negative symptoms of schizophrenia; negative symptoms in schizophrenia; schizophrenia symptoms; negative symptoms of psychosis

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of raloxifene (SERM - Selective Estrogen Receptor Modulator) as an adjuvant of antipsychotic treatment in the management of negative symptoms of schizophrenia in post-menopausal women.

  The primary variable of efficacy will correspond to the change in score on the negative subscale of the PANSS from the start of treatment to the final assessment at 24 weeks. Patients will be considered to respond to treatment if the score in the negative subscale is at least 20% lower than at the start of treatment.

  Change in score on the negative subscale of the PANSS from baseline to final assessment at week 24

Secondary Outcomes (5)

• To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the management of global symptoms of schizophrenia in postmenopausal women.

  From baseline to week 24 (measurements at Baseline, weeks 4, 12, 24)

• To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the global functioning of postmenopausal women with schizophrenia.

  From baseline to week 24 (measurements at Baseline, weeks 4, 12, 24)

• To assess the efficacy of raloxifene as an adjuvant of antipsychotic treatment in the neuropsychological functioning of post-menopausal women with schizophrenia

  From baseline to week 24 (measurements at Baseline, week 12, week 24)

• To control response to treatment as a function of genetic variants in the form of SNP (Single Nucleotide Polymorphisms) that patients present in the alfa (ESR1) and beta (ESR2) estrogenic receptor genes.

  Blood sample collected at Baseline visit

• To assess the safety of the medication used in this patient population.

  From Baseline to week 24

Study Arms (2)

Raloxifene hydrochloride 60 mg

EXPERIMENTAL

Patients fulfilling inclusion criteria and those giving the general informed consent for the study will be randomly allocated to one of the two groups in the trial (placebo or raloxifene) in a 1:1 proportion and in blocks of 4 patients, using the random number tables designed for this purpose. The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Both drugs will be given orally in capsule form. The medication of each of the treatment groups (lactose as placebo, raloxifene) will be introduced into dark green gelatin capsules to guarantee the blinding.

Drug: Raloxifene

Lactosa (placebo)

PLACEBO COMPARATOR

Patients fulfilling inclusion criteria and those giving the general informed consent for the study will be randomly allocated to one of the two groups in the trial (placebo or raloxifene) in a 1:1 proportion and in blocks of 4 patients, using the random number tables designed for this purpose. The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Both drugs will be given orally in capsule form. The medication of each of the treatment groups (lactose as placebo, raloxifene) will be introduced into dark green gelatin capsules to guarantee the blinding.

Drug: Lactosa (placebo arm)

Interventions

Raloxifene DRUG

The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.

Also known as: Raloxifene hydrochloride 60 mg, Laboratory Esteve.

Raloxifene hydrochloride 60 mg

Lactosa (placebo arm) DRUG

Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.

Also known as: Lactosa

Lactosa (placebo)

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia according to DSM-IV TR criteria.
• Postmenopausal patients. Post-menopausal is defined as 1) aged over 45 years with at least one year of amenorrhea and levels of FSH over 20 UI/L or 2) aged over 50 years with at least one year of amenorrhea.
• Patients who have been taking a stable dose of antispsychotic medication for at least the 30 days before the start of the study.
• The presence of significant negative symptoms (defined as one or more negative symptoms with a severity of over 4 on the PANSS scale).
• General written informed consent by patients or their legal representative.
• For the genotypic study, a specific informed consent signed by the patients or legal representative is required.

You may not qualify if:

• A diagnosis of substance abuse/dependence in the previous 6 months.
• Mental retardation
• A diagnosis of major depression (according to DSM-IV TR criteria).
• Endocrine alterations related to sexual hormones, liver insufficiency including cholestasis, severe renal insufficiency.
• History or current condition of thromboembolism, breast cancer, abnormal uterine bleeding or stroke.
• Patients in hormone replacement therapy.
• Known allergy or hypersensitivity to the active ingredient of the investigational drug, or to any of its excipients or lactose.
• To be receiving treatment in another clinical trial.
• To present any severe concomitant disease that in the researcher's opinion can compromise completion of the study or affect the patient's tolerance to this treatment.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Hospital Sant Joan de Deu: collaborator
• Parc Sanitari Sant Joan de Déu: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (3)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Hospital Psiquiàtric Institut Pere Mata

Reus, Tarragona, 43206, Spain

Location

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  PMID: 16235377 RESULT

• Huerta-Ramos E, Labad J, Cobo J, Nunez C, Creus M, Garcia-Pares G, Cuadras D, Franco J, Miquel E, Reyes JC, Marco-Garcia S; RALOPSYCAT Group; Usall J. 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. 2020 Sep;270(6):729-737. doi: 10.1007/s00406-019-01079-w. Epub 2019 Nov 14.

  PMID: 31728631 DERIVED

• Usall J, Huerta-Ramos E, Labad J, Cobo J, Nunez C, Creus M, Pares GG, Cuadras D, Franco J, Miquel E, Reyes JC, Roca M; RALOPSYCAT Group. Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial. Schizophr Bull. 2016 Mar;42(2):309-17. doi: 10.1093/schbul/sbv149. Epub 2015 Nov 20.

  PMID: 26591005 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Judith Usall, PhMD

  Parc Sanitari Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

• Javier Labad Arias, PhMD

  Hospital Psiquiàtric Institut Pere Mata de Reus

  PRINCIPAL INVESTIGATOR

• Gemma García-Parés, PhMD

  Corporació Sanitária Parc Taulí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

ES (3)