deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04019704

A Trial of AXS-05 in Patients With Major Depressive Disorder (GEMINI)

AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder

Sponsor: Axsome Therapeutics, Inc.

Interventions AXS-05 Placebo
Updated 11 times since 2019 Last updated: Sep 16, 2022 Started: Jun 20, 2019 Primary completion: Nov 26, 2019 Completion: Dec 5, 2019
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 Depression and Major Depressive Disorder, this trial is completed. The trial is conducted by Axsome Therapeutics, Inc. and has accumulated 11 data snapshots since 2019. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshotRecruiting~Sep 2019 – ~Nov 2019 · 2 months · monthly snapshotRecruiting~Nov 2019 – ~Feb 2020 · 3 months · monthly snapshotActive Not Recruiting~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshotCompleted~Apr 2021 – ~Oct 2021 · 6 months · monthly snapshotCompleted~Oct 2021 – ~Apr 2022 · 6 months · monthly snapshotCompleted~Apr 2022 – ~Nov 2022 · 7 months · monthly snapshotCompleted~Nov 2022 – ~Jul 2024 · 20 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Nov 2022 — Jul 2024 [monthly]

    Completed PHASE3

  4. Apr 2022 — Nov 2022 [monthly]

    Completed PHASE3

  5. Oct 2021 — Apr 2022 [monthly]

    Completed PHASE3

Show 6 earlier versions
  1. Apr 2021 — Oct 2021 [monthly]

    Completed PHASE3

  2. Jan 2021 — Apr 2021 [monthly]

    Completed PHASE3

  3. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Nov 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  5. Sep 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  6. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

    First recorded

Jun 2019

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Axsome Therapeutics, Inc.
Data source: Axsome Therapeutics, Inc.

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