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NCT02188121 · ClinicalTrials.gov registry record · Phase 4
Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
A Phase 4 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 227
- Enrollment target
NCT02188121 is a Phase 4 study that has completed, run by Mclean Hospital. The registered enrollment target is 227 participants.
The verdict
NCT02188121, a Phase 4 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 227 participants
- Enrollment target
Study 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 exacerbated by treatment with second-generation antipsychotics (2GAs). Although the cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient adherence are central problems to reducing cardiovascular risks for patients with SMI. To address these problems, we propose to conduct a multi-site, open-label, randomized controlled trial comparing an initial treatment strategy of free, fixed-doses of two generic, cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental health clinics versus usual treatment. The study will include adult patients (18+ years old) with schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or psychosis not otherwise specified (NOS) who have received 2GAs treatment within the past six months from within four mental health clinics in the Boston area. We have three aims: 1) to compare the proportions of subjects in each arm who are receiving cardiovascular drug treatment and are adherent to therapy during 12-months of follow-up; 2) to compare changes in composite (e.g., Framingham scores) and individual (e.g., lipid levels) cardiovascular risk factor levels using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels, accounting for variation in adherence over time, using causal inference techniques to estimate the per-protocol effect of the intervention. Our three aims examine whether this low cost, streamlined treatment strategy increases the numbers of subjects receiving cardiovascular prevention therapy and improves cardiovascular risk levels. We will follow subjects for 12 months, and collect interview and biometric data at baseline and over the following 12 mo
Interventions
- DRUG Losartan
- DRUG Simvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2015-02 |
| Est. Completion | 2021-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02188121
The ClinicalTrials.gov registry entry for NCT02188121 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Losartan is the first listed.
NCT02188121 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02188121 about?
NCT02188121 is a clinical study titled "Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients". 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 exacerbated by treatment with second-generation antipsychotics (2GAs). Although the cardiovascular risks are w...
What is the current status of trial NCT02188121?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 227 participants. The study started on 2015-02. Estimated completion is 2021-10.
What interventions are being tested in trial NCT02188121?
The interventions under investigation include: Losartan (DRUG), Simvastatin (DRUG).
Who is sponsoring clinical trial NCT02188121?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
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