Clinical trial NCT01662817: Major Depressive Disorder (MDD)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks
timeFrame: 24 Weeks
Secondary outcomes:
measure: Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks
timeFrame: 24 Weeks
measure: Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks
timeFrame: Baseline, 24 Weeks
measure: Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks
timeFrame: Baseline, 24 Weeks
measure: Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks
timeFrame: Baseline, 24 Weeks
measure: Mean Duration of Depressive Episodes in Patient Participants
timeFrame: 24 Weeks
measure: Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants
timeFrame: 24 Weeks
measure: Sheehan Disability Scale (SDS) Score in Patient Participants
timeFrame: 24 Weeks
measure: Mean Duration of Sick Leave Due to Depression in Patient Participants
timeFrame: 24 Weeks
measure: Percentage of Patient Participants with Sick Leave Due to Depression
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Romera I, Montejo AL, Aragones E, Arbesu JA, Iglesias-Garcia C, Lopez S, Lozano JA, Pamulapati S, Yruretagoyena B, Gilaberte I. Systematic depression screening in high-risk patients attending primary care: a pragmatic cluster-randomized trial. BMC Psychiatry. 2013 Mar 13;13:83. doi: 10.1186/1471-244X-13-83.