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

Last updated: September 23, 2024
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

N/A

Condition

Mood Disorders

Depression (Major/severe)

Depression

Treatment

CT-152 - Digital Therapeutic

Sham

Clinical Study ID

NCT04770285
345-201-00002
  • Ages 22-64
  • All Genders

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.

Eligibility Criteria

Inclusion

Key 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 anADT and who are willing to maintain that same treatment regimen for the duration ofthis trial.

  • Participants who are the only users of an iPhone or an Android smartphone, and agreeto download and use the digital mobile application as required by the protocol.

Exclusion

Key Exclusion Criteria:

  • Participants with an inadequate response to > 1 adequate trial of ADT for thecurrent episode.

  • Participants who are receiving or have received psychotherapy within 90 days priorto screening.

  • Participants who are currently using a computer, web, or smartphone software-basedapplication for mental health or depression.

  • Participants with a history of schizophrenia, schizoaffective disorder, otherpsychotic disorder, or Bipolar I/II disorder, or current posttraumatic stressdisorder, panic disorder, obsessive-compulsive disorder, or personality disorder

  • General Anxiety Disorder/social anxiety can be present as long as they are not themain disorder requiring treatment.

Study Design

Total Participants: 386
Treatment Group(s): 2
Primary Treatment: CT-152 - Digital Therapeutic
Phase:
Study Start date:
February 25, 2021
Estimated Completion Date:
October 26, 2022

Study Description

This is a pivotal, 13-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult participants diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.

The trial consists of a 3-week screening period, a 6-week treatment period, and a 4-week extension. Trial visits will be conducted remotely either by video visit or telephone. The screening visit may be performed in person at the discretion of the investigator. Eligible participants will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the participant's personal iPhone or smartphone.

The trial population will include male and female participants between 22 and 64 years of age with a primary diagnosis of major depressive disorder (MDD) who are on an ADT for the treatment of depression. This trial will analyze data gathered from approximately 360 participants in the United States. An interim analysis will be conducted when a targeted sample of the first 180 participants has completed week 6 or discontinued the trial prior to week 6.

Connect with a study center

  • For additional information regarding sites, contact 844-687-8522

    Dallas, Texas 75231
    United States

    Site Not Available

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