NCT06044818

Brief Summary

Major depressive disorder (MDD) is a chronic disease with a prevalence around 8-12% and is considered one of the most debilitating disease worldwide. A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness. The present study has the objective of validating Accexible as a tool for Screening and Monitoring Depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2025

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

July 13, 2023

Last Update Submit

March 24, 2026

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Depression

    questionnaire

    An average of 1 year

Study Arms (2)

Healthy

Device: Accexible

Depression

Device: Accexible

Interventions

AccexibleDEVICE

Speech Analysis

DepressionHealthy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cases: adults with suspected depression. Controls: healthy controls without depression criteria.

You may qualify if:

  • Adult 18-65 years of age.
  • Participants must have Spanish as their first language (able to speak and understand verbal messages).
  • Participants must have mobile phone with internet.
  • Participants must have the ability to understand AcceXible's basic instructions.
  • Participants must agree to participate in the study and have voluntarily signed the informed consent.

You may not qualify if:

  • To have received a diagnosis of neurodegeneration.
  • To have significant vision problems that would affect the ability to perceive visual stimuli.
  • To have significant hearing problems that would affect the ability to understand verbal cues.
  • To be unable to give informed consent to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron Institut de Investigación (VHIR)

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

September 21, 2023

Study Start

July 10, 2023

Primary Completion

April 17, 2025

Study Completion

April 17, 2025

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

ES(1)