Status:
COMPLETED
Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Takeda
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The current randomized controlled trial is a pilot study that will assess the effectiveness and feasibility of a mobile phone application intervention. The objective is to determine whether the use of...
Detailed Description
This pilot study will be a randomized, real-world effectiveness study. Patients diagnosed with major depressive disorder starting a new prescription for an antidepressant monotherapy will be eligible ...
Eligibility Criteria
Inclusion
- Age 18 to 70
- Ability to consent and participate in study (technical requirements for app: iPhone version 5 or later, active data plan or regular WiFi access)
- Diagnosis with major depressive disorder
- PHQ-9 score greater than 5 at baseline
- Recent (0-14 days) start on monotherapy depression medication (either new prescription or a change from a previous medication)
- Outpatient care provided by participating Advocate Medical Group clinics
Exclusion
- Diagnosis with major psychiatric disorder (e.g. bipolar disorder, manic depressive disorder)
- Contraindications to use of depression medications
- Patients with treatment resistant depression \[defined as patients who have not responded to two or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in the current depressive episode\]
- Considered at imminent risk for hospitalization due to severe depression in the opinion of the treating physician
- History of hospitalization due to major depressive disorder in prior 3 months
- Significant risk of suicide according to the treating physician's clinical judgment or previous suicide attempt in prior 6 months
- History of response only to combination or augmentation therapy in current depressive episode
- Receipt of any investigational compound in prior 30 days (or five half-lives, whichever is longer)
- Current participation in another clinical study
- Lack of functional English literacy
Key Trial Info
Start Date :
July 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03242213
Start Date
July 20 2017
End Date
September 9 2019
Last Update
October 4 2024
Active Locations (1)
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1
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453