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| ID | Type | Description | Link |
|---|---|---|---|
| H6U-XM-S007 | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Intervention group primary care physician (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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | PCP receives one day training in depression screening guidelines and uses guidelines for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary Care Physicians are given the intervention of education to utilize on screened and consented patient participants under the PCP care.
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| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497463 | Derived | Romera I, Montejo AL, Aragones E, Arbesu JA, Iglesias-Garcia C, Lopez S, Lozano JA, Pamulapati S, Yruretagoyena B, Gilaberte I. Systematic depression screening in high-risk patients attending primary care: a pragmatic cluster-randomized trial. BMC Psychiatry. 2013 Mar 13;13:83. doi: 10.1186/1471-244X-13-83. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Control | Behavioral | PCP manages depression in the usual way for six months |
|
| 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 |