N/A
Completed N=386
Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder
Source: ClinicalTrials.gov NCT04770285 ↗Enrolled (actual)
386
Serious AEs
0.3%
Results posted
Oct 2024
Primary outcomePrimary: Change From Baseline to Week 6 in the MADRS Total Score — -9.03; -7.25 score on a scale — p=0.0568
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 6 in the MADRS Total Score |
-9.03; -7.25 | 0.0568 |
| SECONDARY Change From Baseline to Week 6 in the GAD-7 Total Score |
-3.41; -2.64 | 0.0705 |
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.
Data sourced from ClinicalTrials.gov (NCT04770285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.