Clinical trial NCT04770285: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Click Therapeutics, Inc.
First posted: 2021-02-25
Enrollment: 386
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline to Week 6 in the MADRS Total Score
timeFrame: Baseline (Day 1) to Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in the GAD-7 Total Score
timeFrame: Baseline (Day 1) to Week 6
Other outcomes:
measure: Change From Baseline to Weeks 2 and 4 in the MADRS Total Score
timeFrame: Baseline (Day 1) to Weeks 2 and 4
measure: Change From Baseline to Weeks 2 and 4 in the GAD-7 Total Score
timeFrame: Baseline (Day 1) to Weeks 2 and 4
measure: MADRS Response Rate at Weeks 2, 4, and 6
timeFrame: Baseline (Day 1), Weeks 2, 4 and 6
measure: Change From Baseline to Weeks 2, 4 and 6 in the Clinical Global Impression - Severity of Illness (CGI-S) Score
timeFrame: Baseline (Day 1) to Weeks 2, 4 and 6
measure: Change From Baseline to Week 6 in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Total Score
timeFrame: Baseline (Day 1) to Week 6
measure: Change From Screening to Weeks 4 and 6 in the PHQ-9 Total Score.
timeFrame: Screening to Weeks 4 and 6
measure: MADRS Partial Response at Weeks 2, 4 and 6
timeFrame: Baseline (Day 1), Weeks 2, 4 and 6
measure: MADRS Response Rate at Weeks 8 and 10
timeFrame: Baseline (Day 1), Weeks 8 and 10
Locations:
city: Dallas
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Texas
Study officials:
References: