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

NCT01041092 | Completed Phase 4 DMC

• 1 other identifier: 04T-504
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

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.

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

Drug: raloxifene

raloxifene hydrochloride

ACTIVE COMPARATOR

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.

Drug: raloxifene

Interventions

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.

raloxifene hydrochloride; sugar pill

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Fundació Sant Joan de Déu

Esplugues de Llobregat, Spain

Location

Related Publications (2)

• Huerta-Ramos E, Iniesta R, Ochoa S, Cobo J, Miquel E, Roca M, Serrano-Blanco A, Teba F, Usall J. Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. Eur Neuropsychopharmacol. 2014 Feb;24(2):223-31. doi: 10.1016/j.euroneuro.2013.11.012. Epub 2013 Dec 1.

  PMID: 24342775 DERIVED

• Usall J, Huerta-Ramos E, Iniesta R, Cobo J, Araya S, Roca M, Serrano-Blanco A, Teba F, Ochoa S. Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Nov;72(11):1552-7. doi: 10.4088/JCP.10m06610. Epub 2011 Aug 23.

  PMID: 21903021 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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: December 31, 2009
• Study Start: June 1, 2004
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 31, 2009

Record last verified: 2009-12

Locations

ES (1)