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OpenTrials
Completed

NCT Number: NCT01662817

Major Depressive Disorder (MDD)

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

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

Control

Behavioral

PCP manages depression in the usual way for six months

Primary outcomes

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

    Time frame: 24 Weeks

Secondary outcomes

  1. Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks

    Time frame: 24 Weeks

  2. Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks

    Time frame: Baseline, 24 Weeks

  3. Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks

    Time frame: Baseline, 24 Weeks

  4. Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks

    Time frame: Baseline, 24 Weeks

  5. Mean Duration of Depressive Episodes in Patient Participants

    Time frame: 24 Weeks

  6. Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants

    Time frame: 24 Weeks

  7. Sheehan Disability Scale (SDS) Score in Patient Participants

    Time frame: 24 Weeks

  8. Mean Duration of Sick Leave Due to Depression in Patient Participants

    Time frame: 24 Weeks

  9. Percentage of Patient Participants with Sick Leave Due to Depression

    Time frame: 24 Weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 10, 2012
Registry last updated
Aug 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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