Status:
COMPLETED
Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Michael J. Gill Mental Health Clinic
Massachusetts Mental Health Center
Conditions:
Serious Mental Illness
Schizophrenia
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief Summary
Patients with severe mental illness (SMI) die younger than persons in the general population. Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and is exacerbate...
Detailed Description
By design, all subjects in the Intervention arm will start by being under treatment. During the course of follow-up, we expect that some will stay consistently on treatment, some will discontinue trea...
Eligibility Criteria
Inclusion
- Incident or prevalent cases: schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or psychosis NOS (chart diagnosis).
- Age 18 years and older.
- Recent treatment with a standing 2GA, e.g., receiving a standing 2GA in the past 6 months.
- Concomitant psychotropic medications will be allowed.
- Ongoing treatment of their mental illnesses at one of four study mental health clinics, defined as entering one of the two-year First Episode Clinic treatment programs as a de novo patient (new disease) or having been diagnosed \>2 years ago and had at least six visits in the past 12 months (prevalent disease).
Exclusion
- • Unstable/active 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 failure, or both statin and angiotension drug contraindications.
- Unable to provide informed consent, e.g., has dementia, developmental disability, other cognitive disorder, or fails screening mini-mental status exam (subjects with guardians may participate with guardian consent)
- Receiving active cardiovascular treatment, defined as receiving both a statin or ARB in the past three months.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT02188121
Start Date
February 1 2015
End Date
October 1 2021
Last Update
January 30 2023
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478