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

Sponsor

Fundació Sant Joan de Déu (Other)

Overall Status

Completed

CT.gov ID

NCT01041092

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: raloxifene	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: sugar pill	Drug: raloxifene 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.
Active Comparator: raloxifene hydrochloride 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 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.

Arm

Intervention/Treatment

Placebo Comparator: sugar pill

Drug: raloxifene

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.

Active Comparator: raloxifene hydrochloride

Drug: raloxifene

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundació Sant Joan de Déu	Esplugues de Llobregat		Spain

Sponsors and Collaborators

Fundació Sant Joan de Déu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01041092

Other Study ID Numbers:

04T-504

First Posted:

Dec 31, 2009

Last Update Posted:

Dec 31, 2009

Last Verified:

Dec 1, 2009

Additional relevant MeSH terms:

Schizophrenia

Raloxifene Hydrochloride

Study Results

No Results Posted as of Dec 31, 2009