search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIRAI Depression Study Digital Therapetic
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

22 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Digital Therapeutic A

Digital Therapeutic B

Arm Description

Digital Therapeutic Version A

Digital Therapeutic Version B

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 19, 2021
Last Updated
November 14, 2022
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Click Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04770285
Brief Title
Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
Acronym
MIRAI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Click Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Therapeutic A
Arm Type
Other
Arm Description
Digital Therapeutic Version A
Arm Title
Digital Therapeutic B
Arm Type
Other
Arm Description
Digital Therapeutic Version B
Intervention Type
Device
Intervention Name(s)
MIRAI Depression Study Digital Therapetic
Intervention Description
Two different versions of the MIRAI Depression Study digital therapeutics will be compared.
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
From Day 1 to Week 6.
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
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.
Time Frame
From Day 1 to Week 6.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
For additional information regarding sites, contact 844-687-8522
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD Sharing URL
https://clinical-trials.otsuka.com

Learn more about this trial

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

We'll reach out to this number within 24 hrs