NCT04655924

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2022

Geographic Reach
2 countries

11 active sites

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

First Submitted

Initial submission to the registry

November 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 16, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

November 23, 2020

Last Update Submit

January 29, 2024

Conditions

Depression

Keywords

DepressionTreatment SelectionDecision SupportArtificial Intelligence (AI)Machine Learning (ML)

Outcome Measures

Primary Outcomes (2)

  • Rate of Safety - Adverse Events

    Adverse and Serious Adverse Events

    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.

    3 months

Secondary Outcomes (3)

  • Time to Remission

    3 months

  • Response Rate

    3 months

  • Patient Disability with WHODAS rating scale

    3 months

Other Outcomes (3)

  • Number of ER visits, admissions, and re-admissions

    3 months

  • Medication Adherence Rates

    3 months

  • Patient Questionnaire Response Rate

    3 months

Study Arms (2)

Active Intervention

EXPERIMENTAL

Intervention delivered to patients by digital health platform.

Device: Clinical Decision Support System

Active Control

ACTIVE COMPARATOR

Intervention delivered to patients by digital health platform.

Device: Clinical Decision Support System

Interventions

Clinical Decision Support SystemDEVICE

Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform

Active ControlActive Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

VA New Haven, VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

South Florida Veterans Affairs

Miami, Florida, 33125, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Michigan, Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Salem VAMC

Salem, Virginia, 24153, United States

Location

CAMH: The Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, H1N3V2, Canada

Location

CIUSSS De Centre Ouest De L'île de Montréal

Montreal, Quebec, H3T1E2, Canada

Location

McGill University Health Care Centre (MUHC)

Montreal, Quebec, H4A3J1, Canada

Location

CIUSSS De L'Ouest de L'île de Montréal

Montreal, Quebec, H4H1R3, Canada

Location

Douglas Mental Health University Institute

Verdun, Quebec, H4H 1R3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 40875536DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Patient and Rater blinded, Physician partially blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Trial Manager

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 7, 2020

Study Start

June 16, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

With participating site and on request. Further sharing will be determined at a later date.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
To be determined.

Locations

CA(6)US(5)