Status:
COMPLETED
Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Click Therapeutics, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
22-64 years
Phase:
NA
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 treatme...
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 antidepr...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2022
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT04770285
Start Date
February 25 2021
End Date
October 26 2022
Last Update
October 16 2024
Active Locations (1)
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1
For additional information regarding sites, contact 844-687-8522
Dallas, Texas, United States, 75231