deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT05061706

Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Sponsor: Intra-Cellular Therapies, Inc.

Updated 13 times since 2021 Last updated: May 1, 2025 Started: Sep 30, 2021 Primary completion: Apr 12, 2024 Completion: Apr 12, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Major Depressive Disorder, this trial is completed. The trial is conducted by Intra-Cellular Therapies, Inc. and has accumulated 13 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Oct 2021 – ~May 2022 · 7 months · monthly snapshot~May 2022 – ~Jun 2023 · 13 months · monthly snapshot~Jun 2023 – ~Sep 2023 · 3 months · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Apr 2024 · 4 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

13 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Jun 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. May 2025 — Jun 2025 [monthly]

    Completed PHASE3

  4. Apr 2025 — May 2025 [monthly]

    Completed PHASE3

  5. Sep 2024 — Apr 2025 [monthly]

    Completed PHASE3

Show 8 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  2. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  3. Dec 2023 — Apr 2024 [monthly]

    Recruiting PHASE3

  4. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  5. Sep 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  6. Jun 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  7. May 2022 — Jun 2023 [monthly]

    Recruiting PHASE3

  8. Oct 2021 — May 2022 [monthly]

    Recruiting PHASE3

    First recorded

Sep 2021

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Intra-Cellular Therapies, Inc.
Data source: Intra-Cellular Therapies, Inc.

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