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Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD) (B2411003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00770289
First received: October 8, 2008
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's response to treatment. The purpose of this study is the evaluation of the remission rates for patients with MDD. The evaluation will involve the use of HAM-D 17, and HAM-D 7 questionnaires and the comparison of those questionnaires.


Condition Intervention
Major Depressive Disorder
Other: Cohort

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Open Label, Observational, Non-interventional Study for the Evaluation of Remission Rates in Patients With MDD Under Treatment With Various Anti-depressives

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Remission according to HAM-D: HAM-D17 score less than or equal to (=<) 7 or a HAM-D7 score =< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.


Secondary Outcome Measures:
  • Percentage of Participants With Remission Based on Beck Depression Inventory (BDI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Remission according to BDI: BDI score less than (<) 10. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. Total score: 0 to 63; higher score indicates more depression.

  • Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    HAM-D17: clinician-administered scale; assesses 17 items related to major depression (MD). Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: subset of HAM-D17; assesses 7 items related to MD. Total score: 0 to 26. BDI: 21 item participant rated inventory evaluates depression symptoms, cognition, physical symptoms of fatigue, weight loss, lack of interest in sex. Individual item scored on 4 point scale (0 to 3); 0=absent, 3=most severe. Total score: 0 to 63. For all the 3 scales, higher score represented more depression.

  • Number of Participants With Residual Symptoms in Case of Non Remission [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Number of participants with residual symptoms who did not achieve remission was assessed. Remission according to HAM-D: HAM-D17 score =< 7 or HAM-D7 score =<3. Remission according to BDI: BDI score <10. HAM-D17: assessed 17 items associated with MD. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 66. HAM-D7: assessed 7 items associated with MD. Total score: 0 to 26. BDI assessed severity of depressive symptoms. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe. The total score: 0 to 63. For all the 3 scales, higher score indicated more severe depression.


Enrollment: 851
Study Start Date: May 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Single group Other: Cohort
Cohort (Patients diagnosed with MDD who are either changing treatment or have never received treatment).

Detailed Description:

12 weeks random

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients diagnosed with MDD who are either changing treatment or have never received treatment.

Criteria

Inclusion Criteria:

  • Outpatients
  • 18-75 years old
  • Patients diagnosed with MDD according to DSM IV without psychotic symptoms
  • HAM-D17 > or = 18 on inclusion
  • Patients receiving treatment for the first time or changing treatment based on their doctor's decision

Exclusion Criteria:

  • Subjects with potentially problematic compliance
  • Subjects participating in an interventional trial within the last 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770289

Locations
Greece
Pfizer Investigational Site
Haidari, Athens, Greece, 12461
Pfizer Investigational Site
Haidari, Athens, Greece, 12462
Pfizer Investigational Site
Ilissia, Athens, Greece, 11528
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00770289     History of Changes
Other Study ID Numbers: 0600B-102374, B2411003
Study First Received: October 8, 2008
Results First Received: June 6, 2012
Last Updated: August 1, 2012
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014