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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Sant Joan de Déu
• Collaborators: Hospital Sant Joan de Deu; Parc Sanitari Sant Joan de Déu; Stanley Medical Research Institute
• Treatments: Raloxifene Hydrochloride

Criteria

Inclusion criteria:

1. Diagnosis of schizophrenia according to DSM-IV TR criteria.

2. 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.

3. Patients who have been taking a stable dose of antispsychotic medication for at least the 30 days before the start of the study.

4. The presence of significant negative symptoms (defined as one or more negative symptoms with a severity of over 4 on the PANSS scale).

5. General written informed consent by patients or their legal representative.

6. For the genotypic study, a specific informed consent signed by the patients or legal representative is required.

Exclusion criteria:

1. A diagnosis of substance abuse/dependence in the previous 6 months.

2. Mental retardation

3. A diagnosis of major depression (according to DSM-IV TR criteria).

4. Endocrine alterations related to sexual hormones, liver insufficiency including cholestasis, severe renal insufficiency.

5. History or current condition of thromboembolism, breast cancer, abnormal uterine bleeding or stroke.

6. Patients in hormone replacement therapy.

7. Known allergy or hypersensitivity to the active ingredient of the investigational drug, or to any of its excipients or lactose.

8. To be receiving treatment in another clinical trial.

9. 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.