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

Sponsor ID
345-201-00002
Clinicaltrials.gov ID
NCT04770285
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
345-201-00002
Trial Details
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Age
22 - 64 Years
Therapeutic Area
  • Depression
    • Sex
    Female & Male
    Trial Dates
    Feb 2021 - Oct 2022
    Healthy Volunteers
    No
    • 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.
    • 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.

    Study 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.

    Additional Study Details

    Phase
    N/A
    Study Drug
    N/A
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    386
    Additional Study Details

    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

    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.
    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.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    Dallas, Texas, United States, 75231
    Status
    N/A

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