Phase 4 Schizophrenia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing to sign and date a consent form agreeing to take part in the study
• You are willing to follow all study procedures, make lifestyle adjustments, and be available for the full length of the study
• You are a woman between 44 and 55 years old, not currently taking any medications, and are in perimenopause — meaning you have missed at least 2 periods and have gone at least 60 days without a period
• You have started experiencing a loss of pleasure in things (anhedonia) or symptoms of psychosis during the time your periods became irregular
• A clinician has assessed your symptoms as clinically significant using a standard rating scale
• You have a clinically significant level of anhedonia (loss of pleasure or enjoyment), confirmed by a specific questionnaire score
• You are willing to use an estradiol (hormone) skin patch as directed during the study

Who may not be able to join:

• You are currently pregnant, breastfeeding, or trying to become pregnant
• You are allergic to any ingredients in the Climara® patch or Prometrium®
• Your BMI is below 18 or above 35
• You have a history of irregular periods lasting more than 1 year without any period at all
• You have metal in your body, certain dental work, tattoos, or implants that are not 100% plastic, which may prevent MRI scanning (confirm with trial site)
• You have taken part in more than one research study in the past 12 months that involved a significant level of radiation (such as PET or CT scans) — routine medical imaging is not a problem
• You are currently taking psychiatric medications or hormone treatments
• You had a psychiatric illness in the 2 years before your perimenopause began
• You have a history of repeated or long-term mood or psychotic disorders unrelated to reproductive changes
• You have previously been hospitalised for a mood episode
• You are currently experiencing mania
• You had a depressive episode within the past 2 years that was not connected to the transition to menopause
• You have attempted suicide in the past year, or you currently have thoughts of suicide with a plan and intent
• You have a neurological condition, such as a history of seizures or traumatic brain injury
• You have received brain stimulation treatment in the past six months
• You have endometriosis
• You have a close family member (parent or sibling) who had breast cancer before menopause, or breast cancer in both breasts, or more than three family members with breast cancer after menopause
• You are currently taking certain medications including psychiatric drugs, blood pressure medications, cholesterol-lowering drugs, hormonal preparations, or anti-inflammatory medicines more than 10 times per month (some exceptions may apply — confirm with trial site)
• Your last period was more than 12 months ago
• You have a history of unexplained vaginal bleeding
• You have unexplained enlargement of the ovaries
• You have polycystic ovary syndrome (PCOS)
• You have a history of breast or ovarian cancer
• You have a parent or sibling with a history of ovarian cancer
• A breast exam or mammogram has shown an abnormal finding
• You are a known carrier of the BRCA1 or BRCA2 gene mutation
• You have porphyria
• You have malignant melanoma
• You have Hodgkin's disease
• You have recurring migraine headaches that are preceded by an aura (such as visual disturbances)
• You have gallbladder or pancreatic disease (confirm with trial site, as some cases may be reviewed individually)
• You have heart or kidney disease (confirm with trial site, as some cases may be reviewed individually)
• You have liver disease
• You have had a stroke or have cerebrovascular disease
• You have a parent or sibling who has had a heart attack or stroke
• You currently use any nicotine products
• You experience claustrophobia (fear of enclosed spaces)
• You have a peanut allergy

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