Depression - Major Depressive DisorderNCT07578155
Validation of Accexible Screening and Self-Administered Activities for Emotional Well-Being in a University Hospital (UaDEC)
An observational study of Depression - Major Depressive Disorder and Anxiety, run by Accexible at 1 site in Mexico.
Trial summary
Major depressive disorder (MDD) and anxiety are increasingly prevalent among university student populations, yet early detection remains reliant on psychometric instruments tied to diagnostic criteria (e.g., PHQ-9, GAD). Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder, Anxiety
- What is being tested?
- AcceXible
- Type of treatment
- Medical device
- How many people
- 902 participants
- Where
- 1 siteMexico
- Study dates
- 19 Mar 2024to 4 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: University students enrolled at the Universidad Autónoma de Coahuila (UAdeC)
Who may be able to join
- Provision of voluntary written informed consent
- Age 16-25 years
- Current enrollment at BUAP
- Spanish language proficiency
- Access to a mobile device with internet connectivity
- Ability to understand and follow basic acceXible usage instructions
Who cannot join
- Refusal to participate
- Psychomotor agitation
- Sensory impairment (visual or auditory)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Universidad Autónoma de Coahuila (UAdeC)
Saltillo, Coahuila, 25280
About this study
Official title: Validation of the Accexible Screening and Self-administered Activities for Emotional Well-being in a University Hospitalpopulation (UaDEC)
Major depressive disorder (MDD) and anxiety are increasingly prevalent among university student populations, yet early detection remains reliant on psychometric instruments tied to diagnostic criteria (e.g., PHQ-9, GAD). Emerging evidence suggests that depression affects both the acoustic properties and content of speech, making speech analysis a promising candidate as a digital biomarker for early screening.
This study evaluates the validity of acceXible, a speech-based machine learning platform, for the detection and monitoring of depression and anxiety in the student population of the Universidad Autónoma de Coahuila (UAdeC), Mexico. AcceXible captures spontaneous speech through open-ended interview tasks and applies automated acoustic and linguistic analysis.
The primary objective is to evaluate the validity of the acceXible spontaneous speech analysis system for depression and anxiety screening, assessed against the PHQ and GAD scales as reference standards. Secondary objectives include examining associations between speech-derived variables and other study measures, evaluating participant engagement with digital mental health resources, assessing user satisfaction with the platform, and analyzing longitudinal changes in scores across follow-up assessments.
- Conditions
- Depression - Major Depressive Disorder, Anxiety
- Being tested
- AcceXible
- Keywords
- machine learning, speech analysis, depression, anxiety, well-being
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcceXibleDevice
Speech analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of acceXible for depression and anxiety screening
Sensitivity, specificity, and positive predictive value of the acceXible speech analysis system relative to validated Spanish-language versions of the PHQ-9 and GAD-7 as reference standards. Sensitivity is defined as the probability of correctly classifying a participant with abnormal scores; specificity as the probability of correctly classifying a non-affected participant; and positive predictive value as the probability that a participant flagged by acceXible truly meets criteria for depression or anxiety.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start19 Mar 2024
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 902 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accexible
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Autónoma de Coahuila (UAdeC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578155
- Sponsor's protocol ID
- P-FCQ-CIGEN-26-11-2024-1
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Accexible Screening and Self-administered Activities for Emotional Well-being in a University Hospitalpopulation (UaDEC)
- ClinicalTrials.gov ID
- NCT07578155
- Acronym / sponsor ID
- P-FCQ-CIGEN-26-11-2024-1
- Conditions
- Depression - Major Depressive Disorder, Anxiety
- Keywords
- machine learning, speech analysis, depression, anxiety, well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 902 participants (actual)
- Lead sponsor
- AccexibleIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Autónoma de Coahuila (UAdeC)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 11 May 2026 (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) and anxiety are increasingly prevalent among university student populations, yet early detection remains reliant on psychometric instruments tied to diagnostic criteria (e.g., PHQ-9, GAD). Emerging evidence suggests that depression affects both the acoustic properties and content of speech, making speech analysis a promising candidate as a digital biomarker for early screening.
This study evaluates the validity of acceXible, a speech-based machine learning platform, for the detection and monitoring of depression and anxiety in the student population of the Universidad Autónoma de Coahuila (UAdeC), Mexico. AcceXible captures spontaneous speech through open-ended interview tasks and applies automated acoustic and linguistic analysis.
The primary objective is to evaluate the validity of the acceXible spontaneous speech analysis system for depression and anxiety screening, assessed against the PHQ and GAD scales as reference standards. Secondary objectives include examining associations between speech-derived variables and other study measures, evaluating participant engagement with digital mental health resources, assessing user satisfaction with the platform, and analyzing longitudinal changes in scores across follow-up assessments.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- University students enrolled at the Universidad Autónoma de Coahuila (UAdeC)
Key inclusion criteria (6 listed)
- Provision of voluntary written informed consent
- Age 16-25 years
- Current enrollment at BUAP
- Spanish language proficiency
- Access to a mobile device with internet connectivity
Key exclusion criteria (3 listed)
- Refusal to participate
- Psychomotor agitation
- Sensory impairment (visual or auditory)
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 | – |
Primary outcome
Diagnostic accuracy of acceXible for depression and anxiety screening
Time frame: Baseline
Sensitivity, specificity, and positive predictive value of the acceXible speech analysis system relative to validated Spanish-language versions of the PHQ-9 and GAD-7 as reference standards. Sensitivity is defined as the probability of correctly classifying a participant with abnormal scores; specificity as the probability of correctly classifying a non-affected participant; and positive predictive value as the probability that a participant flagged by acceXible truly meets criteria for depression or anxiety.
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 11 May 2026.
- Individual participant dataSharing planned: No
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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 Depression - Major Depressive Disorder and Anxiety, run by Accexible at 1 site in Mexico.
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 6 inclusion and 3 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 11 May 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 Mexico. 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?
Diagnostic accuracy of acceXible for depression and anxiety screening (time frame: Baseline). 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 11 May 2026.