A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder (PERFORM)

July 7, 2015 updated by: H. Lundbeck A/S
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1455

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from outpatient clinics (General Practitioner (GP) or psychiatrist)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Major Depressive Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients' functioning assessed by the Sheehan Disability Scale (SDS) total score
Time Frame: At baseline
At baseline
Patients' functioning assessed by the SDS total score
Time Frame: At 12 months
At 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
At 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13504A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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