Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Mclean Hospital.
NCT02188121 is a Phase 4 study that has completed, run by Mclean Hospital. The registered enrollment target is 227 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02188121 record still lists
NCT02188121 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Losartan is the first listed.
NCT02188121 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02188121's enrollment target sits among peer trials
227 376th of 2000 higher than 1,625 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04751409 · 227 participants · Phase 2
Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities
- NCT05742360 · 227 participants
Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype
- NCT05890352 · 227 participants · Phase 2
Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
- NCT05107908 · 228 participants · NA
Neuronal and Behavioral Effects of an Implicit Priming Approach to Improve Eating Behaviors in Obesity
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia