Bazedoxifene – A New Selective Estrogen Receptor Modulator Treatment for Men with Schizophrenia

Phase 2

• Conditions: Schizophrenia; Mental Health - Schizophrenia

• Registration Number: ACTRN12619001471178
• Lead Sponsor: Monash University Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-23
• Last Update Posted: 28 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

•Physically well.
•A current DSM-V diagnosis of schizophrenia or related disorder.
•18- 65 years
•Able to give informed consent.
•PANSS total score between 40 and 90 and a score of 4 (moderate) or more on two or more of the following PANSS items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness.
•Stable psychotropic medication for previous 4 weeks
•IQ > 70 (as determined by the WAIS IV subtests)
•English language proficiency (in order to provide informed consent and complete cognitive test battery)

Exclusion Criteria

•Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.
•Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.
•Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and/or nicotine dependence).
•Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill.
•Planned changes to psychotropic medication or psychotherapy regimen.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in psychopathology scores using the Positive and Negative Syndrome Scale (PANSS), Montgomery Asberg Depression Rating Scale (MADRS) and the Depression, Anxiety and Stress Scale (DASS-21)[12 weeks post commencement of intervention ]