Brief Summary

The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline

Completed

Started Mar 2011

Geographic Reach

2 countries

13 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

January 19, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed

1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed

Last Updated

January 20, 2011

Status Verified

January 1, 2011

Enrollment Period

1.8 years

First QC Date

January 19, 2011

Last Update Submit

January 19, 2011

Conditions

Schizophrenia Schizoaffective Disorder

Keywords

schizophreniaschizoaffective disorder

Outcome Measures

Primary Outcomes (1)

PANSS total score at the end of the trial.
PANSS will be assesed at weeks 5, 8 and end of study.
3 times

Secondary Outcomes (1)

PANSS,CGI-S, CGI-I, BACS and rates of drop outs before the end of the trial.
PANSS 3 times, CGI-S and CGI-I 5 times and BACS 2 times

Study Arms (2)

raloxifene

EXPERIMENTAL

Drug: raloxifene

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

raloxifeneDRUG

raloxifene 60 mg bid

raloxifene

placeboDRUG

Placebo bid

Placebo

Eligibility Criteria

Age45 Years - 65 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Post menopausal females: Post menopausal defined as: Women 45 years of age and older with no vaginal bleeding for at least 2 years prior to randomization, and both serum estradiol \<73 pmol/L (20 pg/mL) and FSH \>30 IU/L (30 mIU/mL).
years old
Willing and able to provide informed consent, after the nature of the study has been fully explained.
Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.
Symptoms: 4 (moderate) or above on CGI-S and 4 (moderate) score or above on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.
Must be on any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that the dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission.

You may not qualify if:

Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
Women of child bearing potential.
Women who have amenorrhea due to causes other than natural or surgical menopause i.e. eating disorders or exercise
Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.
Patients treated with cholestyramine, warfarin or concurrent systemic estrogen therapy
Likely allergy or sensitivity to raloxifene.
At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.
Patients with hypercoaguable conditions or risk of venous thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sheba Medical Centerlead

Study Sites (13)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Clinica de Psihiatrie, Arad

Arad, Romania

Location

Spitalul de Psihiatrie Botosani

Botoșani, Romania

Location