Major Depressive DisorderPERFORMNCT01427439
A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
An observational study of Major Depressive Disorder, run by H. Lundbeck A/S at 1 site in France.
Trial summary
The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 1,455 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Feb 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from outpatient clinics (General Practitioner (GP) or psychiatrist)
Who may be able to join
- Outpatients with a current or new diagnosis of major depressive episode (MDE) according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR); diagnosis will be confirmed through the Mini International Psychiatric Interview (MINI) questionnaire (depression module)
- Outpatients starting an antidepressant treatment in monotherapy at baseline (treatment initiation or first treatment switch) as decided by the treating physician
- The patient will present within the normal course of care, for either a first or subsequent episode of depression
Who cannot join
- Schizophrenia or other psychotic disorders
- Bipolar disorder
- Dementia or other neurodegenerative disease significantly impacting cognitive functioning
- Mood disorder due to a general medical condition or substances
- Acute suicidality
- Patient treated for depression by a combination of different antidepressant treatments at the time of the consultation
- Other exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Non-interventional study, Observational study
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
Measured: At baseline
Patients' functioning assessed by the SDS total score
Measured: At 12 months
Secondary outcomes (3)
Associations between the patients' clinical condition measured as score on Clinical Global Improvement Severity scale (CGI-S) and of patients' functioning measured as total score on SDS
Measured: At baseline
Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS
Measured: At 12 months
Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe 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
- 1,455 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427439
- Sponsor's protocol ID
- 13504A
- Acronym
- PERFORM
- Status last verified
- Jul 2015
- First submitted
- 26 Aug 2011
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Haro JM, Hammer-Helmich L, Saragoussi D, Ettrup A, Larsen KG. Patient-reported depression severity and cognitive symptoms as determinants of functioning in patients with major depressive disorder: a secondary analysis of the 2-year prospective PERFORM study. Neuropsychiatr Dis Treat. 2019 Aug 13;15:2313-2323. doi: 10.2147/NDT.S206825. eCollection 2019.
PubMed 31616147Haro JM, Lamy FX, Jonsson B, Knapp M, Brignone M, Caillou H, Chalem Y, Hammer-Helmich L, Rive B, Saragoussi D. Characteristics of patients with depression initiating or switching antidepressant treatment: baseline analyses of the PERFORM cohort study. BMC Psychiatry. 2018 Mar 27;18(1):80. doi: 10.1186/s12888-018-1657-3.
PubMed 29587672
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01427439
- Acronym / sponsor ID
- PERFORM / 13504A
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Non-interventional study, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,455 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- First posted
- 1 Sep 2011 (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 describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from outpatient clinics (General Practitioner (GP) or psychiatrist)
Key inclusion criteria (3 listed)
- Outpatients with a current or new diagnosis of major depressive episode (MDE) according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR); diagnosis will be confirmed through the Mini International Psychiatric Interview (MINI) questionnaire (depression module)
- Outpatients starting an antidepressant treatment in monotherapy at baseline (treatment initiation or first treatment switch) as decided by the treating physician
- The patient will present within the normal course of care, for either a first or subsequent episode of depression
Key exclusion criteria (7 listed)
- Schizophrenia or other psychotic disorders
- Bipolar disorder
- Dementia or other neurodegenerative disease significantly impacting cognitive functioning
- Mood disorder due to a general medical condition or substances
- Acute suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
Time frame: At baseline
Patients' functioning assessed by the SDS total score
Time frame: At 12 months
3 secondary outcomes
Associations between the patients' clinical condition measured as score on Clinical Global Improvement Severity scale (CGI-S) and of patients' functioning measured as total score on SDS
Time frame: At baseline
Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS
Time frame: At 12 months
Associations between the patients' clinical condition measured as score on CGI-S and of patients' functioning measured as total score on SDS
Time frame: At 24 months
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 8 Jul 2015.
- Derived from this study: PubMed 31616147Haro JM, Hammer-Helmich L, Saragoussi D, Ettrup A, Larsen KG. Patient-reported depression severity and cognitive symptoms as determinants of functioning in patients with major depressive disorder: a secondary analysis of the 2-year prospective PERFORM study. Neuropsychiatr Dis Treat. 2019 Aug 13;15:2313-2323. doi: 10.2147/NDT.S206825. eCollection 2019.
- Derived from this study: PubMed 29587672Haro JM, Lamy FX, Jonsson B, Knapp M, Brignone M, Caillou H, Chalem Y, Hammer-Helmich L, Rive B, Saragoussi D. Characteristics of patients with depression initiating or switching antidepressant treatment: baseline analyses of the PERFORM cohort study. BMC Psychiatry. 2018 Mar 27;18(1):80. doi: 10.1186/s12888-018-1657-3.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
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 Major Depressive Disorder, run by H. Lundbeck A/S at 1 site in France.
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 3 inclusion and 7 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 8 Jul 2015. 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 France. 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?
Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score (time frame: At baseline). The study lists 2 primary outcomes in all. 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 NCT01427439, which also lists 2 linked publications.
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 8 Jul 2015.