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

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

Detailed Description
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This is a phase 3, 13-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 3-week screening period, a 6-week treatment period, and a 4-week extension period. 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 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 approximately 360 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.

Official Title
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A Multi-center, Randomized, Controlled Trial to Evaluate the Effectiveness of a Digital Therapeutic (CT-152) as Adjunctive Therapy in Adult Subjects Diagnosed With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: MIRAI Depression Study Digital Therapetic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Digital Therapeutic A<br>Digital Therapeutic Version A | Device: MIRAI Depression Study Digital Therapetic<br>* Two different versions of the MIRAI Depression Study digital therapeutics will be compared.<br>|
| Other: Digital Therapeutic B<br>Digital Therapeutic Version B | Device: MIRAI Depression Study Digital Therapetic<br>* Two different versions of the MIRAI Depression Study digital therapeutics will be compared.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Change from Baseline (Day 1) to Week 6 in the MADRS total score. Scores range from 0 to 60 with higher scores indicating worse depressive symptoms. | From Day 1 to Week 6. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalized Anxiety Disorder-7 (GAD-7) | Change from Baseline (Day 1) to Week 6 in GAD-7 total score. Scores range from 0 to 21 with higher scores indicating worse anxiety symptoms. | From Day 1 to Week 6. |