Depression Major Depressive Disorder
Conditions
Interventions
None listed
Sponsors
S.A. Eli Lilly Benelux N.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male or female outpatients aged between 18-64 years - Meeting criteria for MDD as defined by DSM-IV and about to start antidepressant monotherapy at the discretion of the primary care physician - Having personal access to internet and being comfortable with using it (e.g. being a regular user of personal emails) as assessed by the investigator - Having signed a consent form (and confirming this consent via the website within 48 hours after baseline visit at the doctor)
Exclusion criteria
Exclusion criteria: - Patients having received any antidepressant for a depressive episode during the past 6 months - Patients about to start combined antidepressant treatment or a combination of an antidepressant with an antipsychotic or mood stabilizer (continuation of an antiepileptic treatment is allowed) - Have any history of bipolar disorder, psychosis, schizophrenia, or substance dependence (within the last year and with the eception of tobacco or caffeine) - Have a history of stroke or dementia - Being Lilly employee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study will be twofold: A. To assess website feasibility, usability, and data quality of a web-based major depressive disorder assessment tool. Feasibility will be evaluated by means of the inclusion rate of patients starting an antidepressant and the time to patient*s drop out from the web-based tool. Usability will be assessed by means of the patient*s evaluation of the easiness of use, the actual and perceived length of the web-sessions, and the appropriateness of the website as a communication tool with the doctor. Data quality will be evaluated through the completeness of entries. B. To validate the overall prognostic value of the web-based assessment tool in relation to three targeted outcomes: a) remission, b) non-remission with minimal response, and c) non-response 3 and 6 months after starting the antidepressant monotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are: 1. To measure and compare the specific prognostic value of the different variables included in the MDD assessment tool in relation to the three targeted outcomes (remission, nonremission with minimal response and non-response). These variables are the following: - demographic variables - disease history - initiated class of antidepressant - patient-reported adherence to treatment - improvement and speed of improvement in depressive, anxious, and physical symptoms, as well as degree of disability (i.e. functioning). 2. To measure and compare the prognostic value of the different variables included in the MDD assessment tool in relation to two other targeted outcomes: functional recovery and non-recovery at 3 and 6 months. 3. To analyze the functional and health economic burden of patients in remission, nonremission with minimal response and non-response at 3 and 6 months. 4. To analyze the depressive symptoms as measured by the questionnaires of patients in remission, non-remission with minimal response and non-response at 3 and 6 months. 5. To describe discontinuation rates, reasons for discontinuation of the first prescribed antidepressant, and treatment decisions in relation of patients in remission, non-remission with minimal response and non-response at 3 and 6 months. 6. To explore the possibility to define outcome categories by using the web-based questionnaires as compared to remission, non-remission with minimal response and non-response outcome categories by standard methods at 3 and 6 months. 7. To explore primary care physicians interest in the website assessments through a descriptive analyses of the access to the patient self-assessments reports. | — |
Countries
Netherlands
Outcome results
None listed