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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770289
First Posted: October 9, 2008
Last Update Posted: August 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00770289     History of Changes
Other Study ID Numbers: 0600B-102374
B2411003 ( Other Identifier: Pfizer )
First Submitted: October 8, 2008
First Posted: October 9, 2008
Results First Submitted: June 6, 2012
Results First Posted: August 31, 2012
Last Update Posted: August 31, 2012
Last Verified: August 2012

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