NCT02188121
Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
See it on ClinicalTrials.gov ↗204 people
39.7%
60.3%
81 womenmiddle line = equal numbers123 men
- Phase
- PHASE4
- Paid for by
- Mclean Hospital
- Finished
- 2021-10
- Health conditions
- Serious Mental Illness, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Cardiovascular Disease, Major Depressive Disorder, Psychosis NOS
- Who could join
- Anyone
- Ages
- 18 Years – 89 Years
- Average age
- mean 37.2 years
- Age 65+
- Not reported
- Weight (BMI)
- Not reported
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 71.1% · Black / African American 16.7% · Not reported 5.9% · More than one race 3.4% · Asian 2.5% · American Indian / Alaska Native 0.5% · Native Hawaiian / Pacific Islander 0%
Women left out
- No pregnant women
Women who were pregnant could not join.
“…y medications, e.g., diabetes, unstable angina or recent acute coronary syndrome, pregnancy, very high risk factors on the screening labs (e.g., A1c\>7%), renal failure, liver failure, or both statin and angiotension drug contraindications.”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“…y medications, e.g., diabetes, unstable angina or recent acute coronary syndrome, pregnancy, very high risk factors on the screening labs (e.g., A1c\>7%), renal failure, liver failure, or both statin and angiotension drug contraindications.”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“…tential contraindications with both study medications, e.g., diabetes, unstable angina or recent acute coronary syndrome, pregnancy, very high risk factors on the screening labs (e.g., A1c\>7%), renal failure, liver failure, or both statin…”
- No diabetes
Women with diabetes were turned away.
“…ctive disease or potential contraindications with both study medications, e.g., diabetes, unstable angina or recent acute coronary syndrome, pregnancy, very high risk factors on the screening labs (e.g., A1c\>7%), renal failure, liver failu…”
Study titles and rules are shown in their original English.