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Could a menopause drug ease schizophrenia symptoms in women?

NCT ID NCT04113993

Symptom relief Sponsor: The Alfred Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether bazedoxifene, a drug that mimics estrogen, can help reduce schizophrenia symptoms in women when added to their usual antipsychotic medication. 160 women aged 18-65 with schizophrenia or related disorders will receive either bazedoxifene or a placebo daily for 12 weeks. The goal is to see if it improves psychotic symptoms and thinking abilities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bazedoxifene Acetate
What this could lead to
If it works, this could offer a new way to reduce schizophrenia symptoms in women by adding bazedoxifene to their regular antipsychotic medication.
What could go wrong
This is a relatively small, early-phase trial. The drug may not improve symptoms more than placebo, and side effects from the hormone modulator are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Psychotic Disorders schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizo affective disorder Schizophrenia Schizophreniform disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Multidisciplinary Alfred Psychiatry Research Centre

    RECRUITING

    Melbourne, Victoria, 3004, Australia

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