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

NCT ID: NCT04770285

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-25
• Study Completion Date: 2022-10-26

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.

Detailed 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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Digital Therapeutic A - CT-152

Participants 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.

Group Type: OTHER

CT-152 - Digital Therapeutic

Intervention Type: DEVICE

CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.

Digital Therapeutic B - Sham

Participants 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.

Group Type: OTHER

Sham

Intervention Type: DEVICE

Sham mobile app was used by the participants as per the schedule specified in the respective arm.

Interventions

CT-152 - Digital Therapeutic

CT-152 mobile app was used by the participants as per the schedule specified in the respective arm.

Intervention Type: DEVICE

Sham

Sham mobile app was used by the participants as per the schedule specified in the respective arm.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Click Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

For additional information regarding sites, contact 844-687-8522

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39163592 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

345-201-00002

Identifier Type: -

Identifier Source: org_study_id