Major Depressive Disorder (MDD)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effectiveness of systematic screening for depression in high-risk patient participants in everyday clinical practice. Systematic screening for depression in high-risk patients is recommended to be included as a usual practice but its effectiveness in this context remains controversial. In this study, 35 primary care physicians (PCPs) in Spain were assigned to intervention (receive one day training in depression screening guidelines and use guidelines for six months) and 34 PCPs were assigned to a control group (manage depression in the usual way for six months). There were a total of 525 patient participants with MDD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intervention Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months |
Behavioral: Intervention
PCP receives one day training in depression screening guidelines and uses guidelines for six months
|
| Control Control group PCP manages depression in the usual way for six months |
Behavioral: Control
PCP manages depression in the usual way for six months
|
Outcome Measures
Primary Outcome Measures
- Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks [24 Weeks]
Secondary Outcome Measures
- Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks [24 Weeks]
- Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks [Baseline, 24 Weeks]
- Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks [Baseline, 24 Weeks]
- Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks [Baseline, 24 Weeks]
- Mean Duration of Depressive Episodes in Patient Participants [24 Weeks]
- Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants [24 Weeks]
- Sheehan Disability Scale (SDS) Score in Patient Participants [24 Weeks]
- Mean Duration of Sick Leave Due to Depression in Patient Participants [24 Weeks]
- Percentage of Patient Participants with Sick Leave Due to Depression [24 Weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
PCP Participants: PCPs informed of the study design and who agreed to be randomized to the intervention or control group
-
Patient Participants: Aged 18 years or older who provide a written consent for the collection and use of their clinical data
Exclusion Criteria:
-
PCP Participants: If they already follow the recommendations on screening or were planning to do so. If they will be absent from their practice for a significant period during the study, or if they do not usually manage depression
-
PCP Participants: Those who were not able to understand the aims of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Madrid | Spain |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13487
- H6U-XM-S007