Major Depressive Disorder (MDD)NCT06044818
Validation of Accexible as a Tool for Screening and Monitoring Depression.
An observational study of Major Depressive Disorder (MDD), run by Accexible at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Accexible
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2023to 17 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases: adults with suspected depression. Controls: healthy controls without depression criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Vall d'Hebron Institut de Investigación (VHIR)
Barcelona, Barcelona, 08035
About this study
Official title: Validación Del Sistema de Cribaje y Seguimiento de acceXible Para depresión.
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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Accexible
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccexibleDevice
Speech Analysis
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not described Receives: Device: Accexible | |
| Depression | Not described Receives: Device: Accexible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Depression
questionnaire
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start10 Jul 2023
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accexible
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044818
- Sponsor's protocol ID
- PR(AG)86/2023
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validación Del Sistema de Cribaje y Seguimiento de acceXible Para depresión.
- ClinicalTrials.gov ID
- NCT06044818
- Acronym / sponsor ID
- PR(AG)86/2023
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- AccexibleIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: Accexible |
| Depression | – | Device: Accexible |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: adults with suspected depression. Controls: healthy controls without depression criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccexibleSpeech Analysis | Device | Depression, Healthy |
Primary outcome
Prevalence of Depression
Time frame: An average of 1 year
questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder (MDD), run by Accexible at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Depression (time frame: An average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.