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Trial record 4 of 2858 for:    Rating | "Depressive Disorder"

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

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ClinicalTrials.gov Identifier: NCT00770289
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort
Condition Major Depressive Disorder
Intervention Other: Cohort
Enrollment 851

Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
Period Title: Overall Study
Started 851
Completed 845
Not Completed 6
Reason Not Completed
Other             6
Arm/Group Title All Participants
Hide Arm/Group Description All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
Overall Number of Baseline Participants 851
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 851 participants
46.2  (13.2)
[1]
Measure Description: Out of 851 participants, data for the baseline measure, age, was available only for 849 participants.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 851 participants
Female 528
Male 322
Not available 1
1.Primary Outcome
Title Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)
Hide Description 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.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.
Arm/Group Title Hamilton Depression Scale (HAM-D)
Hide Arm/Group Description:
Participants who were administered Hamilton depression scales, HAM-D17 and HAM-D7.
Overall Number of Participants Analyzed 843
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
54.4
(51.1 to 57.8)
2.Secondary Outcome
Title Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)
Hide Description 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.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.
Arm/Group Title Beck Depression Inventory (BDI)
Hide Arm/Group Description:
Participants who were administered BDI.
Overall Number of Participants Analyzed 842
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
64.6
(61.4 to 67.8)
3.Secondary Outcome
Title Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)
Hide Description 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.
Time Frame Baseline, Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available at baseline and were evaluable for this measure.
Arm/Group Title Hamilton Depression Scale (HAM-D17) Hamilton Depression Scale (HAM-D7) Beck Depression Inventory (BDI)
Hide Arm/Group Description:
Participants who were administered HAM-D17.
Participants who were administered HAM-D7, a subset of clinician-administered rating scale HAM-D17.
Participants who were administered BDI.
Overall Number of Participants Analyzed 851 851 850
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 25.18  (5.38) 13.53  (3.22) 31.45  (8.95)
Week 12 7.31  (6.03) 4.07  (3.51) 9.03  (8.03)
Change from baseline at Week 12 17.89  (6.74) 9.48  (3.82) 22.42  (10.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hamilton Depression Scale (HAM-D17), Hamilton Depression Scale (HAM-D7)
Comments Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical testing was done at alpha = 0.05.
Method Pearson's correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson's correlation coefficient
Estimated Value 0.899
Confidence Interval (2-Sided) 95%
0.886 to 0.911
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Hamilton Depression Scale (HAM-D17), Beck Depression Inventory (BDI)
Comments Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical testing was done at alpha = 0.05.
Method Pearson's correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson's correlation coefficient
Estimated Value 0.797
Confidence Interval (2-Sided) 95%
0.771 to 0.820
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hamilton Depression Scale (HAM-D7), Beck Depression Inventory (BDI)
Comments Change from baseline at Week 12: Pearson’s correlation coefficient was used to evaluate compatibility between the questionnaires.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical testing was done at alpha = 0.05.
Method Pearson's correlation
Comments [Not Specified]
Method of Estimation Estimation Parameter Pearson's correlation coefficient
Estimated Value 0.765
Confidence Interval (2-Sided) 95%
0.736 to 0.791
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Residual Symptoms in Case of Non Remission
Hide Description 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.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants. Here, 'N' (number of participants analyzed) signifies those participants who had data available and were evaluable for this measure.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion and did not display remission.
Overall Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: participants
Emotional disorders 59
Sleep disorders 35
Behavioral disorders 22
Anxiety disorders 22
Psychosomatic disorders 20
Sexual disorders 4
No improvement 3
Psychotic disorders 1
Time Frame [Not Specified]
Adverse Event Reporting Description There were no adverse events collected in this observational non-interventional study.
 
Arm/Group Title All Participants
Hide Arm/Group Description All participants diagnosed with major depressive disorder (MDD) who either started treatment with any anti-depressive agent for MDD for the first time or had a change in treatment as per physician's discretion.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/0 
Protocol did not indicate primary or secondary endpoints and designation of endpoints as primary or secondary endpoints was arbitrary.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
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