Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770285
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : March 29, 2021
Sponsor:
Collaborator:
Click Therapeutics, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: MIRAI Depression Study Digital Therapetic Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Controlled Trial to Evaluate the Effectiveness of Digital Therapeutics as Adjunctive Therapy in Adult Subjects Diagnosed With Major Depressive Disorder
Actual Study Start Date : February 19, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Digital Therapeutic A
Digital Therapeutic Version A
Device: MIRAI Depression Study Digital Therapetic
Two different versions of the MIRAI Depression Study digital therapeutics will be compared.

Digital Therapeutic B
Digital Therapeutic Version B
Device: MIRAI Depression Study Digital Therapetic
Two different versions of the MIRAI Depression Study digital therapeutics will be compared.




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: From Day 1 to Week 6. ]
    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 :
  1. Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: From Day 1 to Week 6. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770285


Contacts
Layout table for location contacts
Contact: Otsuka Call Center 844-687-8522 OtsukaUS@druginfo.com

Locations
Layout table for location information
United States, Texas
For additional information regarding sites, contact 844-687-8522 Recruiting
Dallas, Texas, United States, 75231
Contact: Otsuka Call Center    844-687-8522      
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Click Therapeutics, Inc.
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT04770285    
Other Study ID Numbers: 345-201-00002
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
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.
Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
URL: https://clinical-trials.otsuka.com

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms