Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder

Study Identifier:
345-201-00002
ClinicalTrials.gov Identifier:
NCT04770285
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Available

Study Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Study Details

Medical Condition
  • Depression
Study Drug
    Date
    Feb 2021 - Oct 2022
    Phase 1/2
    Phase 2/3
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 22 - 64 Years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Participants with a current primary diagnosis of MDD.
    • Participants with a Hamilton Rating Scale for Depression, 17-item (HAM-D17) score ≥ 18
    • Participants who are receiving treatment with an adequate dose and duration of an ADT and who are willing to maintain that same treatment regimen for the duration of this trial.
    • Participants who are the only users of an iPhone or an Android smartphone, and agree to download and use the digital mobile application as required by the protocol.
    Exclusion Criteria
    • Participants with an inadequate response to \> 1 adequate trial of ADT for the current episode.
    • Participants who are receiving or have received psychotherapy within 90 days prior to screening.
    • Participants who are currently using a computer, web, or smartphone software-based application for mental health or depression.
    • Participants with a history of schizophrenia, schizoaffective disorder, other psychotic disorder, or Bipolar I/II disorder, or current posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, or personality disorder
    • General Anxiety Disorder/social anxiety can be present as long as they are not the main disorder requiring treatment.

    Protocol Summary

    This study compares the effectiveness of 2 digital therapeutics in adult participants diagnosed with major depressive disorder (MDD) who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.

    Study Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    Dallas, Texas, United States, 75231
    Status
    N/A
    © 2025 Otsuka America Pharmaceutical, Inc.
    All rights reserved.

    July 2025 01US25EUC0279

    Requirements information
    Inclusion criteria
    • Participants with a current primary diagnosis of MDD.
    • Participants with a Hamilton Rating Scale for Depression, 17-item (HAM-D17) score ≥ 18
    • Participants who are receiving treatment with an adequate dose and duration of an ADT and who are willing to maintain that same treatment regimen for the duration of this trial.
    • Participants who are the only users of an iPhone or an Android smartphone, and agree to download and use the digital mobile application as required by the protocol.
    Exclusion criteria
    • Participants with an inadequate response to \> 1 adequate trial of ADT for the current episode.
    • Participants who are receiving or have received psychotherapy within 90 days prior to screening.
    • Participants who are currently using a computer, web, or smartphone software-based application for mental health or depression.
    • Participants with a history of schizophrenia, schizoaffective disorder, other psychotic disorder, or Bipolar I/II disorder, or current posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, or personality disorder
    • General Anxiety Disorder/social anxiety can be present as long as they are not the main disorder requiring treatment.

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