Bazedoxifene -Treatment for Women With Schizophrenia

NCT04113993 | Recruiting Phase 4

• 1 other identifier: HREC Reference 47262
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizo Affective Disorder; Schizophreniform Disorders

Outcome Measures

Primary Outcomes (1)

• Schizophrenia symptoms

  Psychopathology rating scales to quantify psychotic and affective symptoms (PANSS)

  12 Weeks

Secondary Outcomes (1)

• Cognition

  12 Weeks

Study Arms (2)

Oral Bazedoxifene

EXPERIMENTAL

Oral Bazedoxifene dosed at 40 mg daily

Drug: Bazedoxifene Acetate

Placebo

PLACEBO COMPARATOR

Identically packaged placebo capsule daily

Drug: Placebo

Interventions

Bazedoxifene Acetate DRUG

Oral Bazedoxifene dosed at 40 mg daily for 12 weeks

Oral Bazedoxifene

Placebo DRUG

Identically packaged placebo capsule daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physically well.
• A current DSM-V diagnosis of schizophrenia or related disorder.
• years
• Able to give informed consent.
• PANSS total score between 40 and 90.
• Documented normal PAP smear and pelvic examination in the preceding two years.
• Stable psychotropic medication for previous 4 weeks
• Normal breast screen (for women aged over 40 years)
• IQ \> 70 (as determined by the WAIS IV subtests)
• English language proficiency (in order to provide informed consent and complete cognitive test battery)

You may not qualify if:

• 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.
• 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 (excluding IUD or Hormone Implants).
• Pregnant (HCG will be measured at screening)
• Breastfeeding
• Planned changes to psychotropic medication or psychotherapy regimen.

Sponsors & Collaborators

• The Alfred: lead
• Monash University: collaborator

Study Sites (1)

Multidisciplinary Alfred Psychiatry Research Centre

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

bazedoxifene

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Anthony de Castella

CONTACT

+61 390766564; Anthony.decastella@monash.edu

MAPrc

CONTACT

+61 390766564; maprc@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomised to receive either activie treatment or identically packaged placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Multidisciplinary Alfred Psychiatry research centre

Model Details: This randomized, double-blind, placebo-controlled, 12-week trial will be conducted at two sites- the lead site is the Multidisciplinary Alfred Psychiatry research Centre in Melbourne (Investigator - Prof Jayashri KULKARNI). The trial will follow the parallel comparison design consisting of two arms over 12 weeks (treatment x time). Participants will be screened to ensure inclusion / exclusion criteria are met.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: October 3, 2019
• Study Start: October 7, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

AU (1)