Major Depressive Disorder (MDD)

Eli Lilly and Company525 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

525

Conditions

Depression

Interventions

InterventionBEHAVIORAL

PCP receives one day training in depression screening guidelines and uses guidelines for six months

ControlBEHAVIORAL

PCP manages depression in the usual way for six months

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Time frame: 24 Weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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