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

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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.

Tracking Information
First Submitted Date  ICMJE February 19, 2021
First Posted Date  ICMJE February 25, 2021
Last Update Posted Date March 29, 2021
Actual Study Start Date  ICMJE February 19, 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Evaluate the Effectiveness of Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
Official Title  ICMJE A Multi-center, Randomized, Controlled Trial to Evaluate the Effectiveness of Digital Therapeutics as Adjunctive Therapy in Adult Subjects Diagnosed With Major Depressive Disorder
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Device: MIRAI Depression Study Digital Therapetic
Two different versions of the MIRAI Depression Study digital therapeutics will be compared.
Study Arms  ICMJE
  • Digital Therapeutic A
    Digital Therapeutic Version A
    Intervention: Device: MIRAI Depression Study Digital Therapetic
  • Digital Therapeutic B
    Digital Therapeutic Version B
    Intervention: Device: MIRAI Depression Study Digital Therapetic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2021)
540
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Otsuka Call Center 844-687-8522 OtsukaUS@druginfo.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04770285
Other Study ID Numbers  ICMJE 345-201-00002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Click Therapeutics, Inc.
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP