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

Major Depressive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04770285
• Other study ID #: 345-201-00002
• Status: Completed
• Phase: Phase 3
• Start date: February 25, 2021
• Est. completion date: October 26, 2022

Study information

• Verified date: May 2024
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a pivotal, 13-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult participants 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. 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 participants will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the participant's personal iPhone or smartphone.

The trial population will include male and female participants 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 participants in the United States. An interim analysis will be conducted when a targeted sample of the first 180 participants has completed week 6 or discontinued the trial prior to week 6.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 64 Years

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• CT-152 - Digital Therapeutic
Participants will receive digital treatment session using the CT-152 mobile application (app) from Day 1 up to Week 6 of the treatment period. This will consist of Emotional Faces Memory Task (EFMT) exercises, a cognitive behavioral therapy (CBT)-based lesson and SMS messages.
• Sham
Participants will receive digital treatment session by using a sham mobile app from Day 1 up to Week 6 of the treatment period. This will consist of a Shapes Memory Task (SMT) exercise and SMS messages.

Locations

Country	Name	City	State
United States	For additional information regarding sites, contact 844-687-8522	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Click Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From Day 1 to Week 6
Secondary	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.	From Day 1 to Week 6