Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
Condition: Serious Mental Illness; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Cardiovascular Disease; Major Depressive Disorder; Psychosis NOS
MeSH terms: Cardiovascular Diseases; Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Intervention: Simvastatin; Losartan
Intervention description: 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors; Angiotensin II receptor antagonist
Intervention MeSH terms: Losartan; Simvastatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No

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 months. Subjects will have the option to continue for another 12 months, during
      which we will continue to collect interview and biometric data, but will not prescribe
      cardiovascular medications. This population-based initial treatment strategy could be an
      effective and efficient approach for overcoming traditional barriers to cardiovascular
      disease prevention within the SMI population. Findings from this study will inform efforts to
      improve care and outcomes, and to enhance survival for patients with severe mental illness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  • 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.