Major Depressive Disorder (MDD)
Effectiveness of Physicians' Education, Implementation and Follow up of Current Recommendations Regarding Screening for Major Depressive Disorder in High Risk Patients on Improving the Under-Recognition Rates of Depression in Primary Care
2 other identifiers
observational
525
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedAugust 10, 2012
August 1, 2012
10 months
July 27, 2012
August 8, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks
24 Weeks
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
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
Interventions
PCP receives one day training in depression screening guidelines and uses guidelines for six months
Eligibility Criteria
Primary Care Physicians are given the intervention of education to utilize on screened and consented patient participants under the PCP care.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (1)
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.
PMID: 23497463DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2012
First Posted
August 10, 2012
Study Start
September 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
August 10, 2012
Record last verified: 2012-08