A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder (PERFORM)
This study is currently recruiting participants.
Verified March 2013 by H. Lundbeck A/S
Sponsor:
H. Lundbeck A/S
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01427439
First received: August 26, 2011
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.
| Condition |
|---|
|
Major Depressive Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder |
Resource links provided by NLM:
Further study details as provided by H. Lundbeck A/S:
Primary Outcome Measures:
- Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score [ Time Frame: At baseline ] [ Designated as safety issue: No ]
- Patients' functioning assessed by the SDS total score [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Major Depressive Disorder |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients will be recruited from outpatient clinics (General Practitioner (GP) or psychiatrist)
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427439
Contacts
| Contact: Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
Locations
| France | |
| FR | Recruiting |
| Paris, France | |
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
| Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
More Information
No publications provided
| Responsible Party: | H. Lundbeck A/S |
| ClinicalTrials.gov Identifier: | NCT01427439 History of Changes |
| Other Study ID Numbers: | 13504A |
| Study First Received: | August 26, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: Committee for the Protection of Personnes France: Conseil National de l'Ordre des Médecins France: The Commission nationale de l’informatique et des libertés Germany: Ethics Commission Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica Sweden: Regional Ethical Review Board United Kingdom: Research Ethics Committee |
Keywords provided by H. Lundbeck A/S:
|
MDD Non-interventional study Observational study |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013