Phase 4 Schizophrenia Trial, Recruiting NCT04113993 Sponsor: The Alfred Condition: Schizophrenia
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Phase 4 Schizophrenia Trial, Recruiting

NCT04113993
Recruiting Phase 4 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are currently in good physical health
  • People who have a current diagnosis of schizophrenia or a related condition, as defined by DSM-V criteria
  • People aged between 18 and 65 years old
  • People who are able to understand and agree to take part in the trial (give informed consent)
  • People whose symptom score on a standard schizophrenia rating scale (called the PANSS) falls between 40 and 90
  • People who have had a normal cervical screening test (Pap smear) and pelvic examination within the past two years
  • People who have been on the same psychiatric medications without changes for at least the past four weeks
  • Women aged over 40 who have had a normal breast screen (mammogram) within the past two years
  • People with an IQ above 70, as measured by a specific cognitive test (WAIS IV subtests)
  • People who are sufficiently proficient in English to give informed consent and complete a cognitive test battery

Who may not be able to join:

  • People with known problems affecting the hormonal system connecting the brain and reproductive organs, thyroid problems, brain tumours, or a current or past history of blood clots in the veins
  • People with a history of severe brain injury, significant neurological conditions, unstable medical conditions such as epilepsy or diabetes, or known active heart, kidney, or liver disease, or a condition that limits their ability to move around
  • People whose psychotic illness appears to be directly caused by illicit drug use, or who have had a problem with substance dependence in the last six months (not including caffeine or nicotine)
  • Women aged 40 or over who have not had a normal mammogram within the last 24 months
  • People who have used any form of oestrogen, progestin, or androgen hormone therapy — including the contraceptive pill — in the past four weeks (hormonal IUDs or hormonal implants are not excluded — confirm with trial site)
  • People who are currently pregnant (a pregnancy test will be done at screening)
  • People who are currently breastfeeding
  • People who have planned changes to their psychiatric medications or psychotherapy during the trial period

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +61 390766564

Australian sites

Multidisciplinary Alfred Psychiatry Research Centre, Melbourne, Victoria
+61 3 9076 6924

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
The Alfred
Registry
ClinicalTrials.gov
Start date
7 October 2019
Est. completion
31 December 2026

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Schizophrenia symptoms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov