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

• ClinicalTrials.gov Identifier: NCT04770285
• Recruitment Status: Completed
• First Posted: February 25, 2021
• Last Update Posted: November 15, 2022
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Click Therapeutics, Inc.
• Information provided by (Responsible Party): Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information

• First Submitted Date: February 19, 2021
• First Posted Date: February 25, 2021
• Last Update Posted Date: November 15, 2022
• Actual Study Start Date: February 19, 2021
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

Device: MIRAI Depression Study Digital Therapetic

Two different versions of the MIRAI Depression Study digital therapeutics will be compared.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 7, 2022): 386
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 26, 2022
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04770285
• Other Study ID Numbers: 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

• 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: Statistical Analysis Plan (SAP)
• 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 the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• URL: https://clinical-trials.otsuka.com

• Current Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Original Study Sponsor: [Redacted]
• Collaborators: Click Therapeutics, Inc.
• Investigators: Not Provided
• PRS Account: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Verification Date: November 2022