Dallas, Texas 75231

  • Major Depressive Disorder

Purpose:

This study compares the effectiveness and safety of 2 digital therapeutics in adult subjects diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression.


Study summary:

This is a phase 3, 12-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult subjects diagnosed with MDD who are on antidepressant therapy (ADT) monotherapy for the treatment of depression. The trial consists of a 2-week screening period, a 6-week treatment period, and a 4-week extension period. All trial visits will be conducted remotely either by video visit or telephone. Eligible subjects will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the subject's personal iPhone or smartphone. The trial population will include male and female subjects 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 up to 540 subjects in the United States. An interim analysis will be conducted when a targeted sample of the first 180 subjects has completed week 6 or discontinued the trial prior to week 6.


Criteria:

Key Inclusion Criteria: - Subjects with a current primary diagnosis of MDD. - Subjects with a Hamilton Rating Scale for Depression, 17-item (HAM-D17) score ≥ 18 - Subjects 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. - Subjects 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. Key Exclusion Criteria: - Subjects with an inadequate response to > 1 adequate trial of ADT for the current episode. - Subjects who are receiving or have received psychotherapy within 90 days prior to screening. - Subjects who are currently using a computer , web, or smartphone software-based application for mental health or depression. - Subjects 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.


NCT ID:

NCT04770285


Primary Contact:

Otsuka Call Center
Phone: 844-687-8522
Email: OtsukaUS@druginfo.com


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75231
United States

Otsuka Call Center
Phone: 844-687-8522

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

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