DepressionNCT04061642
A Feasibility Study of an AI-Powered Clinical Decision Aid for Personalized Depression Treatment Selection
A study testing Clinical Decision Aid in people with Depression, run by Aifred Health Inc. at 1 site in Canada.
Trial summary
The Clinical Decision Aid (CDA) is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve… 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 Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 16 Dec 2019to 31 Dec 2020
- 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
Who may be able to join
- All patients of the physicians in the study are diagnosed with major depressive disorder by a physician using DSM-V criteria.
- All participants must be able to provide informed consent.
- Contraception will be used as per established clinical guidelines and usual clinical practice for medications known to cause birth defects. The medications prescribed and the use of and type of contraception will be determined by the physicians in the study in consultation with their patients as would usually occur in clinical practice.
Who cannot join
- Bipolar disorder type 1 or 2, as the data we have used to train the model does not allow for generalization to bipolar disorder (either pre-existing or as diagnosed according to DSM-5 criteria).
- Inability or unwillingness of individual to give informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Douglas Mental Health University Institute
Verdun, Quebec, H4H 1R3
About this study
Official title: A Feasibility Study of a Hybrid-Classic/Deep-Learning Enabled Clinical Decision Aid for Personalized and Individualized Pharmacological Depression Treatment Selection
The Clinical Decision Aid (CDA) is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be presented to the physician who will then make a treatment choice.
Read the detailed description
Hypothesis 1. There will not be a significant difference in measured non-initial intake appointment lengths between the baseline period and the appointment length measured at two and four months after introduction of the study software and CDA.
Hypothesis 2. Physicians will not subjectively report that using the CDA and study software increased the length of their appointments.
Hypothesis 3. At least 66% of patients and 66% of physicians will rate the trustworthiness of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater trust).
Hypothesis 4. At least 66% of patients and 66% of physicians will rate the overall usability of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater usability).
Hypothesis 5. At least 70% of physicians and 65% of patients will still be using the application regularly by the end of the study. For physicians, regularly will be defined as the application being used in every study-related visit. For patients regularly will be defined as completing at least one PHQ-9 and GAD-7 questionnaire on the application per week.
Exploratory hypothesis: Based on our machine learning results to date, we expect between 40-50% of patients starting a new treatment for depression and whose treatment follows the highest probability treatment output by the CDA to remit within 14 weeks. This is exploratory, and the study is not necessarily powered to demonstrate this.
- Conditions
- Depression
- Being tested
- Clinical Decision Aid
- Keywords
- Artificial intelligence, Deep learning, Clinical decision aid
- 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 AidDevice
The Clinical Decision Aid is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of all possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be ordered by efficacy and presented to the physician. Lifestyle interventions, such as exercise or mindfulness, which have an evidence base, but do not require formal regulatory approval, will also be outputted. The system will additionally produce a side effect profile for each pharmacological treatment recommended, including known side effects, modified by a prediction about which side effects may be more likely for a given individual based on their individual characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Aid | Experimental | Not described Receives: Device: Clinical Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective length of outpatient visits
Measured: Through study completion, 6 months
Objective length of outpatient visits
Measured: Through study completion, 6 months
Physician retention rates
Measured: Through study completion, 6 months
Patient retention rates
Measured: Through study completion, 6 months
Patient self-rated experience using the study software
We will be using our Clinical Decision Aid Feasibility Questionnaire (Version 1), a descriptive questionnaire with 5-point Likert scales (with higher values representing better outcomes) and narrative questions about experience using the tool.
Measured: Through study completion, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start16 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aifred Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061642
- Sponsor's protocol ID
- IUSMD-19-08
- Status last verified
- Mar 2021
- First submitted
- 5 Aug 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Popescu C, Golden G, Benrimoh D, Tanguay-Sela M, Slowey D, Lundrigan E, Williams J, Desormeau B, Kardani D, Perez T, Rollins C, Israel S, Perlman K, Armstrong C, Baxter J, Whitmore K, Fradette MJ, Felcarek-Hope K, Soufi G, Fratila R, Mehltretter J, Looper K, Steiner W, Rej S, Karp JF, Heller K, Parikh SV, McGuire-Snieckus R, Ferrari M, Margolese H, Turecki G. Evaluating the Clinical Feasibility of an Artificial Intelligence-Powered, Web-Based Clinical Decision Support System for the Treatment of Depression in Adults: Longitudinal Feasibility Study. JMIR Form Res. 2021 Oct 25;5(10):e31862. doi: 10.2196/31862.
PubMed 34694234
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Hybrid-Classic/Deep-Learning Enabled Clinical Decision Aid for Personalized and Individualized Pharmacological Depression Treatment Selection
- ClinicalTrials.gov ID
- NCT04061642
- Acronym / sponsor ID
- IUSMD-19-08
- Conditions
- Depression
- Keywords
- Artificial intelligence, Deep learning, Clinical decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Aifred Health Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Aug 2019 (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.
The Clinical Decision Aid (CDA) is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be presented to the physician who will then make a treatment choice.
Detailed description
Hypothesis 1. There will not be a significant difference in measured non-initial intake appointment lengths between the baseline period and the appointment length measured at two and four months after introduction of the study software and CDA.
Hypothesis 2. Physicians will not subjectively report that using the CDA and study software increased the length of their appointments.
Hypothesis 3. At least 66% of patients and 66% of physicians will rate the trustworthiness of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater trust).
Hypothesis 4. At least 66% of patients and 66% of physicians will rate the overall usability of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater usability).
Hypothesis 5. At least 70% of physicians and 65% of patients will still be using the application regularly by the end of the study. For physicians, regularly will be defined as the application being used in every study-related visit. For patients regularly will be defined as completing at least one PHQ-9 and GAD-7 questionnaire on the application per week.
Exploratory hypothesis: Based on our machine learning results to date, we expect between 40-50% of patients starting a new treatment for depression and whose treatment follows the highest probability treatment output by the CDA to remit within 14 weeks. This is exploratory, and the study is not necessarily powered to demonstrate this.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Aid | Experimental | Device: Clinical Decision Aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients of the physicians in the study are diagnosed with major depressive disorder by a physician using DSM-V criteria.
- All participants must be able to provide informed consent.
- Contraception will be used as per established clinical guidelines and usual clinical practice for medications known to cause birth defects. The medications prescribed and the use of and type of contraception will be determined by the physicians in the study in consultation with their patients as would usually occur in clinical practice.
Key exclusion criteria (2 listed)
- Bipolar disorder type 1 or 2, as the data we have used to train the model does not allow for generalization to bipolar disorder (either pre-existing or as diagnosed according to DSM-5 criteria).
- Inability or unwillingness of individual to give informed consent.
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 AidThe Clinical Decision Aid is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of all possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be ordered by efficacy and presented to the physician. Lifestyle interventions, such as exercise or mindfulness, which have an evidence base, but do not require formal regulatory approval, will also be outputted. The system will additionally produce a side effect profile for each pharmacological treatment recommended, including known side effects, modified by a prediction about which side effects may be more likely for a given individual based on their individual characteristics. | Device | Clinical Decision Aid |
Primary outcome
Subjective length of outpatient visits
Time frame: Through study completion, 6 months
Objective length of outpatient visits
Time frame: Through study completion, 6 months
Physician retention rates
Time frame: Through study completion, 6 months
Patient retention rates
Time frame: Through study completion, 6 months
Patient self-rated experience using the study software
Time frame: Through study completion, 6 months
We will be using our Clinical Decision Aid Feasibility Questionnaire (Version 1), a descriptive questionnaire with 5-point Likert scales (with higher values representing better outcomes) and narrative questions about experience using the tool.
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 17 Mar 2021.
- Derived from this study: PubMed 34694234Popescu C, Golden G, Benrimoh D, Tanguay-Sela M, Slowey D, Lundrigan E, Williams J, Desormeau B, Kardani D, Perez T, Rollins C, Israel S, Perlman K, Armstrong C, Baxter J, Whitmore K, Fradette MJ, Felcarek-Hope K, Soufi G, Fratila R, Mehltretter J, Looper K, Steiner W, Rej S, Karp JF, Heller K, Parikh SV, McGuire-Snieckus R, Ferrari M, Margolese H, Turecki G. Evaluating the Clinical Feasibility of an Artificial Intelligence-Powered, Web-Based Clinical Decision Support System for the Treatment of Depression in Adults: Longitudinal Feasibility Study. JMIR Form Res. 2021 Oct 25;5(10):e31862. doi: 10.2196/31862.
- Individual participant dataSharing planned: Yes
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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?
A study testing Clinical Decision Aid in people with Depression, run by Aifred Health Inc. at 1 site in Canada.
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 3 inclusion and 2 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 17 Mar 2021. 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 Canada. 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?
Subjective length of outpatient visits (time frame: Through study completion, 6 months). The study lists 5 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 NCT04061642, 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 17 Mar 2021.