Major Depressive Disorder (MDD)

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662817
• Other study ID #: 13487
• Secondary ID: H6U-XM-S007
• Status: Completed
• Phase: N/A
• First received: July 27, 2012
• Last updated: August 8, 2012
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Behavioral:
• Intervention
PCP receives one day training in depression screening guidelines and uses guidelines for six months
• Control
PCP manages depression in the usual way for six months

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks		24 Weeks	No
Secondary	Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks		24 Weeks	No
Secondary	Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks		Baseline, 24 Weeks	No
Secondary	Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks		Baseline, 24 Weeks	No
Secondary	Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks		Baseline, 24 Weeks	No
Secondary	Mean Duration of Depressive Episodes in Patient Participants		24 Weeks	No
Secondary	Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants		24 Weeks	No
Secondary	Sheehan Disability Scale (SDS) Score in Patient Participants		24 Weeks	No
Secondary	Mean Duration of Sick Leave Due to Depression in Patient Participants		24 Weeks	No
Secondary	Percentage of Patient Participants with Sick Leave Due to Depression		24 Weeks	No