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Completed

NCT Number: NCT01041092

Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women

Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women.

This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Treatment period of 12 weeks.

The primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. The investigators also found improved response in some aspects of social functioning and neuropsychological functioning.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fundació Sant Joan de Déu

Esplugues de Llobregat, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of schizophrenia (DSM-IV criteria)
  • Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level > 20IU/L.
  • Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
  • Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
  • Patients have to give written informed consent to participate in the study.

Exclusion criteria

  • Patients with a substance abuse/dependence diagnosis in the previous six months.
  • Mental retardation.
  • Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
  • History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
  • Patients taking hormone replacement therapy.
  • Patients taking mood stabilizer medication that cannot be discontinued.

Treatment and study plan

Raloxifene

Drug

Dose of raloxifene hydrochloride will be: 60mg /day. Patients are required to continue taking their regular medications throughout the duration of the study. No changes in dose will be required during the study period. Double-blind treatment will continue for 12 weeks.

Primary outcomes

  1. The primary efficacy end-point will be the change in the score of the PANSS negative subscale from baseline to follow-up assessment.

Secondary outcomes

  1. Patients social and neuropsychological functioning will be evaluated, comparing baseline ratings to end-point.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Official study title

Double Blind, Placebo-controlled Study of Efficacy, Safety and Tolerance of Raloxifene as an Adjuvant Treatment for Negative Symptoms of Schizophrenia in Postmenopausal Women

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Dec 31, 2009
Registry last updated
Dec 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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