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
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 |
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Spain,
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 |
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