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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 August 2015 |
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Main ID: |
NCT01427439 |
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Date of registration:
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26/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder
PERFORM |
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Scientific title:
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A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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1455 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01427439 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Email contact via H. Lundbeck A/S |
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Address:
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Telephone:
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Email:
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Affiliation:
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LundbeckClinicalTrials@lundbeck.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depressive Disorder
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Primary Outcome(s)
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Patients' functioning assessed by the SDS total score
[Time Frame: At 12 months]
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Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
[Time Frame: At baseline]
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Secondary Outcome(s)
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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]
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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]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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