A randomized trial administering Raloxifene vs. Placebo as add-on to antipsychotics in post menopausal patients with schizophrenia or schizoaffecive disorder

Phase 1

• Conditions: schizophrenia or schizoaffecive disorder

• Registration Number: EUCTR2010-023983-42-RO
• Lead Sponsor: The Stanley Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-25
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1.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).
2.45-65 years old
3.Willing and able to provide informed consent, after the nature of the study has been fully explained.
4.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.
5.Symptoms: 4 (moderate) or above on CGI-S and ? 4 (moderate) score 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.
6.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.
7.Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
2.Women of child bearing potential.
3.Women who have amenorrhea due to causes other than natural or surgical menopause i.e. eating disorders or exercise
4.Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning.
5.Patients treated with cholestyramine, warfarin or concurrent systemic estrogen therapy
6.Likely allergy or sensitivity to raloxifene.
7.At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
8.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.
9.Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Primary outcome measure: PANSS total score at the end of the trial. <br>Secondary outcome measures: PANSS positive, negative and general psychopathology scales, Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I), Brief Assessment of Cognition in Schizophrenia (BACS) and rates of drop outs before the end of the trial. <br>;Primary end point(s): Primary outcome measure: PANSS total score at the end of the trial.