Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT04113993
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04113993
Study Brief:
Protocol Section:
NCT04113993