If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Phase 4 study for people with Schizophrenia

Recruiting Phase 4

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 4
Sponsor The Alfred
Registry number NCT04113993
Started 7 October 2019 Today 16 October 2026 Estimated completion 31 December 2026

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Multidisciplinary Alfred Psychiatry Research Centre Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years to 65 Years
Sex Female participants only
Healthy volunteers Not accepted
Enrolment target 160

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 7 October 2019
Estimated completion 31 December 2026
Registry last updated 3 June 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 3 June 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.