Major Depressive Disorder (MDD)

Completed

• Conditions: Depression
• Interventions: Behavioral: Intervention; Behavioral: Control

• Registration Number: NCT01662817
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2012-07-27
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-08
• Last Update Submitted: 2012-08-08
• Study First Posted: 2012-08-10
• Last Update Posted: 2012-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months
Control	Control	Control group PCP manages depression in the usual way for six months

Primary Outcome Measures

Name	Time	Method
Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks	24 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (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