Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients (FITNESS)
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|ClinicalTrials.gov Identifier: NCT02188121|
Recruitment Status : Unknown
Verified October 2019 by Dost Ongur, Mclean Hospital.
Recruitment status was: Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Statin and/or Angiotensin Receptor Blocker
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
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.
- 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 ]
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|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Dost Ongur, MD PhD||Mclean Hospital|