Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
MIRAI
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
1 other identifier
interventional
386
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable major-depressive-disorder
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2022
CompletedResults Posted
Study results publicly available
October 16, 2024
CompletedOctober 16, 2024
September 1, 2024
1.7 years
February 19, 2021
September 23, 2024
September 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 6 in the MADRS Total Score
The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a more severe level of depression. A negative change from baseline indicates improvement. Least square (LS) mean was estimated using Mixed Model Repeated Measures (MMRM) method.
Baseline (Day 1) to Week 6
Secondary Outcomes (1)
Change From Baseline to Week 6 in the GAD-7 Total Score
Baseline (Day 1) to Week 6
Other Outcomes (8)
Change From Baseline to Weeks 2 and 4 in the MADRS Total Score
Baseline (Day 1) to Weeks 2 and 4
Change From Baseline to Weeks 2 and 4 in the GAD-7 Total Score
Baseline (Day 1) to Weeks 2 and 4
MADRS Response Rate at Weeks 2, 4, and 6
Baseline (Day 1), Weeks 2, 4 and 6
- +5 more other outcomes
Study Arms (2)
Digital Therapeutic A - CT-152
OTHERParticipants received digital treatment session by using the CT-152 mobile application (app) from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of Emotional Faces Memory Task (EFMT) exercises and a psychotherapy lesson. From Week 7 up to Week 10 participants continued using the CT-152 app with optional psychotherapy lesson but did not receive any new EFMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed CT-152 treatment courses.
Digital Therapeutic B - Sham
OTHERParticipants received digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. Each treatment session consisted of a Shape and Memory Task (SMT) exercise only. From Week 7 up to Week 10 participants continued using the sham app but did not receive any new SMT exercises during this period. Participants continued receiving brief SMS messages during Weeks 7 to 10 as a reminder of the previously completed sham treatment courses.
Interventions
CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.
Sham mobile app was used by the participants as per the schedule specified in the respective arm.
Eligibility Criteria
You may qualify if:
- 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 an ADT and who are willing to maintain that same treatment regimen for the duration of this trial.
- Participants 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.
You may not qualify if:
- Participants with an inadequate response to \> 1 adequate trial of ADT for the current episode.
- Participants who are receiving or have received psychotherapy within 90 days prior to screening.
- Participants who are currently using a computer, web, or smartphone software-based application for mental health or depression.
- Participants 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
For additional information regarding sites, contact 844-687-8522
Dallas, Texas, 75231, United States
Related Publications (1)
Rothman B, Slomkowski M, Speier A, Rush AJ, Trivedi MH, Lawson E, Fahmy M, Carpenter D, Chen D, Forbes A. Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study. JMIR Res Protoc. 2024 Aug 20;13:e56960. doi: 10.2196/56960.
PMID: 39163592DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2021
First Posted
February 25, 2021
Study Start
February 25, 2021
Primary Completion
October 26, 2022
Study Completion
October 26, 2022
Last Updated
October 16, 2024
Results First Posted
October 16, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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 the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
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.