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Completed

NCT Number: NCT02188121

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 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.

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Key information

Conditions

Serious Mental Illness Bipolar Disorder Bipolar and Related Disorders Cardiovascular Disease Cardiovascular Diseases Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Psychosis NOS Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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 treatment (become non-adherent), while others will make transitions on and off treatment in various patterns. In contrast, by design, subjects in the Usual Treatment (control) arm do not start on treatment; however, some will initiate treatment as a result of usual clinical care, e.g., primary care physician initiation. At any point we will be comparing two binary outcomes (on or off treatment) and will use standard methods for comparing two proportions to test statistical significance and get confidence intervals for the difference in the percent on treatment in the two arms. Participants who are ineligible for randomization will be followed similarly to participants in the Usual Treatment Arm, in a third, non-randomized group, which will be excluded from the primary analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors

Losartan

Drug

Angiotensin II receptor antagonist

Primary outcomes

  1. Number of Participants on Adequate Cardiovascular Prevention Care (Defined as Taking a Statin and Angiotensin Medication)

    Time frame: Baseline to 12 months

Secondary outcomes

  1. Change in Low Density Lipoprotein Levels

    Time frame: Baseline to 12 months

    Similar to secondary outcome measure but focusing on Low Density Lipoprotein, Systolic Blood Pressure, and Hemoglobin A1c

Other outcomes

  1. Change in Modified Framingham Score as a Summary Cardiovascular Risk Level

    Time frame: Baseline and 3, 6, 9, and 12 months

    The outcome here is the difference in summary risk level changes (e.g., modified Framingham score) between our two study groups, i.e., do intervention subjects experience differential changes in cardiovascular risk levels compared to control subjects. This outcome will be continuously measured (but not necessarily normally distributed).

  2. Change in Number of Distinct Cardiovascular Prevention Drugs Taken

    Time frame: Baseline and 3, 6, 9, and 12 months

    Similar to primary outcome measure, but here we count the number of distinct cardiovascular prevention drugs taken by the patient as a continuous measure to reflect potential for partial treatment.

  3. Change in Systolic Blood Pressure

    Time frame: Baseline and 3, 6, 9, and 12 months

    Similar to secondary outcome measure but focusing on Systolic Blood Pressure

  4. Change in Hemoglobin A1C

    Time frame: Baseline and 3, 6, 9, and 12 months

    Similar to secondary outcome measure but focusing on Hemoglobin A1c

  5. Change in Percent on Adequate Cardiovascular Prevention Care

    Time frame: Baseline to 3 months

  6. Change in Percent on Adequate Cardiovascular Prevention Care

    Time frame: Baseline to 6 months

  7. Change in Percent on Adequate Cardiovascular Prevention Care

    Time frame: Baseline to 9 months

  8. Mean Percentage of Follow up Time During Which Each Group is on Adequate Cardiovascular Prevention Care

    Time frame: Baseline to 12 months

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital
  • Massachusetts Mental Health Center
  • Michael J. Gill Mental Health Clinic
  • The Edinburg Center

Registry information

Official study title

Fixed Dose Intervention Trial of New England Enhancing Survival in Serious Mental Illness Patients

Acronym: FITNESS

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jul 11, 2014
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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