deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT02188121

Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients (FITNESS)

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

Sponsor: Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital

Conditions Bipolar Disorder Cardiovascular Disease Major Depressive Disorder Psychosis NOS Schizoaffective Disorder Schizophrenia Serious Mental Illness
Interventions Losartan Simvastatin
Updated 15 times since 2017 Last updated: Jan 4, 2023 Started: Feb 28, 2015 Primary completion: Oct 31, 2020 Completion: Oct 31, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02188121, this PHASE4 trial focuses on Bipolar Disorder and Cardiovascular Disease and remains completed. Sponsored by Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital, it has been updated 15 times since 2015, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2018 · 13 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Aug 2019 · 11 months · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshot~Jan 2021 – ~Nov 2021 · 10 months · monthly snapshot~Nov 2021 – ~Sep 2022 · 10 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – present · 18 months · monthly snapshot

Change History

15 versions recorded

  1. Feb 2025 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Feb 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE4

  5. Dec 2022 — Feb 2023 [monthly]

    Completed PHASE4

▶ Show 10 earlier versions

  1. Sep 2022 — Dec 2022 [monthly]

    Completed PHASE4

    Status: Unknown Status → Completed

  2. Nov 2021 — Sep 2022 [monthly]

    Unknown Status PHASE4

    Status: Active Not Recruiting → Unknown Status

  3. Jan 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE4

  4. Nov 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE4

    Status: Recruiting → Active Not Recruiting

  5. Aug 2019 — Nov 2019 [monthly]

    Recruiting PHASE4

  6. Sep 2018 — Aug 2019 [monthly]

    Recruiting PHASE4

  7. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE4

  8. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE4

  9. Feb 2017 — Mar 2018 [monthly]

    Recruiting PHASE4

  10. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE4

    First recorded

Feb 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital
  • Massachusetts Mental Health Center
  • Mclean Hospital
  • Michael J. Gill Mental Health Clinic
  • The Edinburg Center
Data source: Mclean Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations