Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients (FITNESS)
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ClinicalTrials.gov Identifier: NCT02188121 |
Recruitment Status :
Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : October 8, 2019
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Condition or disease | Intervention/treatment | Phase |
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Serious Mental Illness Schizophrenia Schizoaffective Disorder Bipolar Disorder Cardiovascular Disease Major Depressive Disorder Psychosis NOS | Drug: Simvastatin Drug: Losartan | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 268 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Fixed Dose Intervention Trial of New England Enhancing Survival in Serious Mental Illness Patients |
Study Start Date : | February 2015 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2021 |

Arm | Intervention/treatment |
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Experimental: Statin and/or Angiotensin Receptor Blocker
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
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Drug: Simvastatin
3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors Drug: Losartan Angiotensin II receptor antagonist |
No Intervention: Usual treatment
We will compare the initial treatment intervention with usual treatment (control arm), with both arms superimposed on a system of regular monitoring base. The investigators will make no effort to alter or influence treatment or use of that treatment for subjects in the control arm. Note that our goal in the Control arm is to characterize "usual treatment". We will not intervene in this care except in emergencies. Some patients who need care for metabolic syndrome may not be receiving it - just as they would if not in our trial.
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- Change in percentage of participants on adequate cardiovascular prevention care (defined as taking a statin and angiotensin medication) [ Time Frame: Baseline to 12 months ]
- 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).
- 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.
- Change in Low Density Lipoprotein levels [ Time Frame: Baseline and 3, 6, 9, and 12 months ]Similar to secondary outcome measure but focusing on Low Density Lipoprotein, Systolic Blood Pressure, and Hemoglobin A1c
- 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
- Change in Hemoglobin A1C [ Time Frame: Baseline and 3, 6, 9, and 12 months ]Similar to secondary outcome measure but focusing on Hemoglobin A1c
- Change in percent on adequate cardiovascular prevention care [ Time Frame: Baseline to 3 months ]
- Change in percent on adequate cardiovascular prevention care [ Time Frame: Baseline to 6 months ]
- Change in percent on adequate cardiovascular prevention care [ Time Frame: Baseline to 9 months ]
- Mean percentage of follow up time during which each group is on adequate cardiovascular prevention care [ Time Frame: Baseline to 12 months ]

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Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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• 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188121
United States, Massachusetts | |
McLean Hospital | |
Belmont, Massachusetts, United States, 02478 |
Principal Investigator: | Dost Ongur, MD PhD | Mclean Hospital |
Documents provided by Dost Ongur, Mclean Hospital:
Responsible Party: | Dost Ongur, Chief of Psychotic Disorders Division at McLean Hospital and Associate Professor in Psychiatry at Harvard Medical School, Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT02188121 |
Other Study ID Numbers: |
PHS IRB pending |
First Posted: | July 11, 2014 Key Record Dates |
Last Update Posted: | October 8, 2019 |
Last Verified: | October 2019 |
Cardiovascular Diseases Disease Schizophrenia Depressive Disorder Depressive Disorder, Major Bipolar Disorder Psychotic Disorders Mental Disorders Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Mood Disorders Bipolar and Related Disorders Losartan |
Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |