DepressionAID-MENCT04655924
Artificial Intelligence in Depression - Medication Enhancement
A study testing Clinical Decision Support System in people with Depression, run by Aifred Health at 11 sites in 2 countries.
Trial summary
This study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Clinical Decision Support System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 16 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion Criteria:
- diagnosed with major depressive disorder by a physician using DSM-V criteria
- able to provide informed consent
- patients must confirm that they are comfortable being treated for depression by their physician, who may propose a range of treatment options, such as medications or psychotherapies, consistent with best practice guidelines for depression which are included in the application. Physicians will be required, as in usual practice, to explain treatments to patients and patients will be able to give and withdraw consent for treatment in general or for specific treatments as in usual practice.
Patient Exclusion Criteria:
- bipolar disorder of any type
- inability or unwillingness of the individual to give informed consent
- inability to manage patient in an outpatient setting (i.e. imminent suicidality)
- active major depression is not the main condition being treated (i.e. the patient has depressive symptoms in the context of severe substance abuse or a psychotic disorder, but a primary diagnosis of major depressive episode (MDE) cannot be made or would result in inappropriate care).
- inability to use the tool (i.e. patient cannot interface with a mobile phone or computer due to delirium, or another medical condition)* *Note that for patients who do not have access to mobile or desktop devices but are able to use them or to be trained to use them, these will be provided to them at no cost.
Physician Inclusion Criteria:
- any family doctor/primary care physician or psychiatrist accredited in Canada or the USA who treats patients with depression on at least a monthly basis, as well as residents from these specialities supervised by a participating physician
- able to provide informed consent
- comfortable prescribing the range of potential treatments which could have probabilities provided for them by the CDA
No Physician Exclusion Criteria
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Canada6 sites
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, Quebec, H1N3V2
CIUSSS De Centre Ouest De L'île de Montréal
Montreal, Quebec, H3T1E2
McGill University Health Care Centre (MUHC)
Montreal, Quebec, H4A3J1
CIUSSS De L'Ouest de L'île de Montréal
Montreal, Quebec, H4H1R3
CAMH: The Centre for Addiction and Mental Health
Toronto, Ontario, M6J1H4
Douglas Mental Health University Institute
Verdun, Quebec, H4H 1R3
United States5 sites
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
South Florida Veterans Affairs
Miami, Florida, 33125
Salem VAMC
Salem, Virginia, 24153
VA New Haven, VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Artificial Intelligence in Depression - Medication Enhancement: A Randomized, Patient and Rater Blinded, Active-Controlled Trial of a Hybrid-Classic/Machine-Learning Enabled Clinical Decision Aid for Personalized and Individualized Pharmacological Depression Treatment Selection
This study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment.
- Conditions
- Depression
- Being tested
- Clinical Decision Support System
- Keywords
- Depression, Treatment Selection, Decision Support, Artificial Intelligence (AI), Machine Learning (ML)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support SystemDevice
Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | Intervention delivered to patients by digital health platform. Receives: Device: Clinical Decision Support System |
| Active Control | Active comparator | Intervention delivered to patients by digital health platform. Receives: Device: Clinical Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Safety - Adverse Events
Adverse and Serious Adverse Events
Measured: 3 months
Effectiveness in Reduction of Depression Symptoms
This is approved as a physician partially-blinded study and, as such, physicians are blinded to the primary outcome.
Measured: 3 months
Secondary outcomes (3)
Time to Remission
To evaluate time to remission between groups. The hypothesis is that time to remission will be shorter in the active intervention group compared to the active control group.
Measured: 3 months
Response Rate
To evaluate response rate between groups. The hypothesis is that the response rate (defined as 50% improvement in symptoms) and time to response, will be higher and lower, respectively, in the active intervention group compared to the active control group.
Measured: 3 months
Patient Disability with WHODAS rating scale
To evaluate between-group differences in patient disability outcomes. The hypothesis is that the physicians in the active intervention arm will produce superior patient outcomes to those physicians using usual guideline-informed practice, in terms of patient function as measured by a rating scale (WHODAS).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start16 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Clinical Decision Aid is a digital health platform that collects patient data and provides reports and analyses to clinicians that can assist them in their decision making about treatment selection and management.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aifred Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University
- Responsible party
- Sponsor-investigator, Aifred Health, Aifred Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655924
- Sponsor's protocol ID
- IUSMD 18-04
- Acronym
- AID-ME
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2020
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: With participating site and on request. Further sharing will be determined at a later date.
Publications
Benrimoh D, Whitmore K, Richard M, Golden G, Perlman K, Jalali S, Friesen T, Barkat Y, Mehltretter J, Fratila R, Armstrong C, Israel S, Popescu C, Karp JF, Parikh SV, Golchi S, Moodie EEM, Shen J, Gifuni AJ, Ferrari M, Sapra M, Kloiber S, Pinard GF, Dunlop BW, Looper K, Ranganathan M, Enault M, Beaulieu S, Rej S, Hersson-Edery F, Steiner W, Anacleto A, Qassim S, McGuire-Snieckus R, Margolese HC. Artificial Intelligence in Depression-Medication Enhancement (AID-ME): A Cluster Randomized Trial of a Deep-Learning-Enabled Clinical Decision Support System for Personalized Depression Treatment Selection and Management. J Clin Psychiatry. 2025 Aug 27;86(3):24m15634. doi: 10.4088/JCP.24m15634.
PubMed 40875536
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in Depression - Medication Enhancement: A Randomized, Patient and Rater Blinded, Active-Controlled Trial of a Hybrid-Classic/Machine-Learning Enabled Clinical Decision Aid for Personalized and Individualized Pharmacological Depression Treatment Selection
- ClinicalTrials.gov ID
- NCT04655924
- Acronym / sponsor ID
- AID-ME / IUSMD 18-04
- Conditions
- Depression
- Keywords
- Depression, Treatment Selection, Decision Support, Artificial Intelligence (AI), Machine Learning (ML)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Aifred HealthIndustry (pharma, biotech, devices)
- Collaborators
- McGill University
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Dec 2020 (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.
This study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The Clinical Decision Aid is a digital health platform that collects patient data and provides reports and analyses to clinicians that can assist them in their decision making about treatment selection and management.
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Device: Clinical Decision Support SystemIntervention delivered to patients by digital health platform. |
| Active Control | Active comparator | Device: Clinical Decision Support SystemIntervention delivered to patients by digital health platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Clinical Decision Support SystemClinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform | Device | Active Control, Active Intervention |
Primary outcome
Rate of Safety - Adverse Events
Time frame: 3 months
Adverse and Serious Adverse Events
Effectiveness in Reduction of Depression Symptoms
Time frame: 3 months
This is approved as a physician partially-blinded study and, as such, physicians are blinded to the primary outcome.
3 secondary outcomes
Time to Remission
Time frame: 3 months
Response Rate
Time frame: 3 months
Patient Disability with WHODAS rating scale
Time frame: 3 months
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 30 Jan 2024.
- Derived from this study: PubMed 40875536Benrimoh D, Whitmore K, Richard M, Golden G, Perlman K, Jalali S, Friesen T, Barkat Y, Mehltretter J, Fratila R, Armstrong C, Israel S, Popescu C, Karp JF, Parikh SV, Golchi S, Moodie EEM, Shen J, Gifuni AJ, Ferrari M, Sapra M, Kloiber S, Pinard GF, Dunlop BW, Looper K, Ranganathan M, Enault M, Beaulieu S, Rej S, Hersson-Edery F, Steiner W, Anacleto A, Qassim S, McGuire-Snieckus R, Margolese HC. Artificial Intelligence in Depression-Medication Enhancement (AID-ME): A Cluster Randomized Trial of a Deep-Learning-Enabled Clinical Decision Support System for Personalized Depression Treatment Selection and Management. J Clin Psychiatry. 2025 Aug 27;86(3):24m15634. doi: 10.4088/JCP.24m15634.
- Individual participant dataSharing planned: Yes. With participating site and on request. Further sharing will be determined at a later date.
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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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support System in people with Depression, run by Aifred Health at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, United States. 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?
Rate of Safety - Adverse Events (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655924, which also lists 1 linked publication.
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 30 Jan 2024.