Bazedoxifene -Treatment for Women With Schizophrenia

NCT ID: NCT04113993

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2025-12-31

Brief Summary

To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.

Detailed Description

Despite advances in the treatment of schizophrenia, pharmacotherapy remains sub- optimal, and the prognosis for many patients is poor. We have pioneered work showing that estradiol has a positive role in the treatment of psychosis symptoms and cognitive deficits seen in people with schizophrenia. However, with the longer-term work from studies such as the Women's Health Initiative (1), it has become clear that long-term use of estradiol with progesterone may have associated increased risks of breast and other cancers. Hence, we began working with the Selective Estrogen Receptor Modulator - raloxifene, which appears to be safer for longer term use with respect to the development of breast and other cancers. Building on our and others work, raloxifene used as an adjunctive treatment in schizophrenia appears to produce inconsistent and varying responses in different sub-populations; gender, menopausal status, age, drug dose and delivery mode. We now propose to conduct a double-blind, randomized, placebo controlled trial of a third generation SERM - bazedoxifene - which is 4 times more selective for the alpha than the beta oestrogen receptor subtype. Bazedoxifene appears to be safer with respect to long term use than older SERMs, has additional actions on the glucocorticoid receptor, and together this different pharmacology speculatively has greater potential than other SERMs to impact favorably on both psychosis symptoms and cognition in men and women with schizophrenia. This study will test 160 women to determine if bazedoxifene, as an adjunctive hormone modulator, is effective for positive and cognitive symptoms of schizophrenia.

Conditions

Schizophrenia; Schizophreniform Disorders; Schizo Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Bazedoxifene

Oral Bazedoxifene dosed at 40 mg daily

Group Type: EXPERIMENTAL

Bazedoxifene Acetate

Intervention Type: DRUG

Oral Bazedoxifene dosed at 40 mg daily for 12 weeks

Placebo

Identically packaged placebo capsule daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identically packaged placebo capsule daily

Interventions

Bazedoxifene Acetate

Oral Bazedoxifene dosed at 40 mg daily for 12 weeks

Intervention Type: DRUG

Placebo

Identically packaged placebo capsule daily

Intervention Type: DRUG

Eligibility Criteria

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.
• Documented normal PAP smear and pelvic examination in the preceding two years.
• Stable psychotropic medication for previous 4 weeks
• Normal breast ultrasound
• 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).
• Women aged 40 or over who have not had a normal mammogram in the last 24 months
• Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill.
• Pregnant (HCG will be measured at screening)
• Breastfeeding
• Planned changes to psychotropic medication or psychotherapy regimen.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: collaborator

Monash Health

OTHER

Sponsor Role: collaborator

The Alfred

OTHER

Sponsor Role: lead

Responsible Party

Jayashri Kulkarni, Professor

Director of Monash Alfred Psychiatry research centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Anthony de Castella, Applied Scince

Role: CONTACT

Anthony.decastella@monash.edu

+61 390766564

MAPrc

Role: CONTACT

maprc@monash.edu

+61 390766564

Facility Contacts

Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD

Role: primary

j.kulkarni@alfred.org.au

+61 3 9076 6924

Anthony deCastella, Dip App Sci, BA, MA

Role: backup

anthony.decastella@monash.edu

+61 3 9076 6554 ext. 66554

Other Identifiers

HREC Reference 47262

Identifier Type: -

Identifier Source: org_study_id