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NCT04770285 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
NA
Development phase
386
Enrollment target

NCT04770285: Completed NA study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT04770285 is a NA study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 386 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04770285, a NA study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
NA
Development phase
386 participants
Enrollment target

Study 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.

Primary Outcome

The MADRS is used to assess depressive symptom severity. It consists of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated from 0 to 6 with zero being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The total score ranges from 0 to 60. A higher score on the MADRS represents a mo

Interventions

  • DEVICE Sham
  • DEVICE CT-152 - Digital Therapeutic

Trial Details

FieldValue
Enrollment Target 386 participants
Start Date 2021-02-25
Est. Completion 2022-10-26
Phase NA

What the finished NCT04770285 record still lists

NCT04770285 is an interventional study that assigns participants to a tested intervention. The registered 386 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.

NCT04770285 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04770285 about?

NCT04770285 is a clinical study titled "Trial to Evaluate the Effectiveness of a Digital Therapeutics in Adults Diagnosed With Major Depressive Disorder". 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.

What is the current status of trial NCT04770285?

This trial is currently completed. It is a NA study. The enrollment target is 386 participants. The study started on 2021-02-25. Estimated completion is 2022-10-26.

What interventions are being tested in trial NCT04770285?

The interventions under investigation include: Sham (DEVICE), CT-152 - Digital Therapeutic (DEVICE).

Who is sponsoring clinical trial NCT04770285?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04770285's enrollment target sits among peer trials

386 271st of 2000 higher than 1,730 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04770285, the US trial registry maintained by the National Library of Medicine. NCT04770285 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.