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Major Depressive Disorder (MDD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01662817
First received: July 27, 2012
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Depression
 Behavioral: Intervention
Behavioral: Control

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Mean Duration of Depressive Episodes in Patient Participants [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale (SDS) Score in Patient Participants [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Mean Duration of Sick Leave Due to Depression in Patient Participants [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patient Participants with Sick Leave Due to Depression [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment: 525
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention
Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months
 Behavioral: Intervention
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
 Behavioral: Control
PCP manages depression in the usual way for six months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary Care Physicians are given the intervention of education to utilize on screened and consented patient participants under the PCP care.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662817

Locations
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, Spain
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01662817     History of Changes
Other Study ID Numbers: 13487, H6U-XM-S007
Study First Received: July 27, 2012
Last Updated: August 8, 2012
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013