Major Depressive Disorder (MDD)

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2010

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks
    • Time Frame: 24 Weeks

Secondary Measures

  • Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks
    • Time Frame: 24 Weeks
  • Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks
    • Time Frame: Baseline, 24 Weeks
  • Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks
    • Time Frame: Baseline, 24 Weeks
  • Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks
    • Time Frame: Baseline, 24 Weeks
  • Mean Duration of Depressive Episodes in Patient Participants
    • Time Frame: 24 Weeks
  • Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants
    • Time Frame: 24 Weeks
  • Sheehan Disability Scale (SDS) Score in Patient Participants
    • Time Frame: 24 Weeks
  • Mean Duration of Sick Leave Due to Depression in Patient Participants
    • Time Frame: 24 Weeks
  • Percentage of Patient Participants with Sick Leave Due to Depression
    • Time Frame: 24 Weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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), Study Director, Eli Lilly and Company

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