DepressionNCT01662817
Major Depressive Disorder (MDD)
An observational study of Depression, run by Eli Lilly and Company at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 525 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Care Physicians are given the intervention of education to utilize on screened and consented patient participants under the PCP care.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
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
About this study
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
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.
- Conditions
- Depression
- Being tested
- Intervention, Control
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
PCP receives one day training in depression screening guidelines and uses guidelines for six months
ControlBehavioural
PCP manages depression in the usual way for six months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Intervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months Receives: Behavioral: Intervention | |
| Control | Control group PCP manages depression in the usual way for six months Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks
Measured: 24 Weeks
Secondary outcomes (9)
Percentage of Patient Participants with Under-Treatment of MDD Episodes at 24 Weeks
Measured: 24 Weeks
Change from Baseline in Primary Care Physician (PCP) Adherence to Intervention Questionnaire at 24 Weeks
Measured: Baseline, 24 Weeks
Change from Baseline in PCP Feasibility of Intervention Questionnaire at 24 Weeks
Measured: Baseline, 24 Weeks
Change from Baseline in PCP Acceptance of Intervention Questionnaire at 24 Weeks
Measured: Baseline, 24 Weeks
Mean Duration of Depressive Episodes in Patient Participants
Measured: 24 Weeks
Clinical Global Impressions: Severity (CGI-S) Score in Patient Participants
Measured: 24 Weeks
Sheehan Disability Scale (SDS) Score in Patient Participants
Measured: 24 Weeks
Mean Duration of Sick Leave Due to Depression in Patient Participants
Measured: 24 Weeks
Percentage of Patient Participants with Sick Leave Due to Depression
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662817
- Sponsor's protocol ID
- 13487
- Other IDs
- H6U-XM-S007
- Status last verified
- Aug 2012
- First submitted
- 27 Jul 2012
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23497463
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01662817
- Acronym / sponsor ID
- 13487
- Conditions
- Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: InterventionIntervention group primary care physician (PCP) receives one day training in depression screening guidelines and uses guidelines for six months |
| Control | – | Behavioral: ControlControl group PCP manages depression in the usual way for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Physicians are given the intervention of education to utilize on screened and consented patient participants under the PCP care.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionPCP receives one day training in depression screening guidelines and uses guidelines for six months | Behavioural | Intervention |
| ControlPCP manages depression in the usual way for six months | Behavioural | Control |
Primary outcome
Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks
Time frame: 24 Weeks
9 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
- Derived from this study: PubMed 23497463Romera 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Eli Lilly and Company at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patient Participants with Under-Recognized Major Depressive Disorder (MDD) Episodes at 24 Weeks (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01662817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.