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Major Depressive Disorder (MDD)

NCT ID: NCT01662817

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

525 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months

Intervention

Intervention Type BEHAVIORAL

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

Control

Intervention Type BEHAVIORAL

PCP manages depression in the usual way for six months

Interventions

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Intervention

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

Intervention Type BEHAVIORAL

Control

PCP manages depression in the usual way for six months

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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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

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 23497463 (View on PubMed)

Other Identifiers

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H6U-XM-S007

Identifier Type: OTHER

Identifier Source: secondary_id

13487

Identifier Type: -

Identifier Source: org_study_id