deltatrials
Completed PHASE3 INTERVENTIONAL 7-arm NCT02751632

The Staged Treatment in Early Psychosis Study (STEP)

Staged Treatment in Early Psychosis (STEP): A Sequential Multistage Randomized Clinical Trial (SMART) of Interventions for Ultra High Risk (UHR) of Psychosis Patients.

Sponsor: National Institute of Mental Health (NIMH)

Conditions Clinical High Risk Personality Disorders Psychotic Disorders
Interventions 3-monthly monitoring Cognitive Behavioural Case Management Fluoxetine Placebo Support and Problem Solving Therapy
Updated 14 times since 2017 Last updated: Sep 29, 2025 Started: Apr 30, 2016 Primary completion: Jul 31, 2019 Completion: May 31, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02751632, this PHASE3 trial focuses on Clinical High Risk and Personality Disorders and remains completed. Sponsored by National Institute of Mental Health (NIMH), it has been updated 14 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Oct 2017 · 9 months · monthly snapshot~Oct 2017 – ~Apr 2018 · 6 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Jul 2019 · 9 months · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Oct 2020 · 13 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Nov 2022 · 13 months · monthly snapshot~Nov 2022 – ~Jul 2024 · 20 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2025 · 14 months · monthly snapshot~Nov 2025 – present · 8 months · monthly snapshot

Change History

14 versions recorded

  1. Nov 2025 — Present [monthly]

    Completed PHASE3

    Status: Unknown → Completed

  2. Sep 2024 — Nov 2025 [monthly]

    Unknown PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown Status → Unknown

  4. Nov 2022 — Jul 2024 [monthly]

    Unknown Status PHASE3

    Status: Active Not Recruiting → Unknown Status

  5. Oct 2021 — Nov 2022 [monthly]

    Active Not Recruiting PHASE3

▶ Show 9 earlier versions

  1. Jan 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  2. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2019 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Oct 2018 — Jul 2019 [monthly]

    Recruiting PHASE3

  6. Jun 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  7. Apr 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  8. Oct 2017 — Apr 2018 [monthly]

    Recruiting PHASE3

  9. Jan 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Mental Health (NIMH)
  • Orygen
  • University of California, Davis
  • University of California, San Francisco
Data source: Orygen

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

Study Locations