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Trial record 4 of 2811 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Participants 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.

Participant Flow:   Overall Study
    All Participants
STARTED   851 
COMPLETED   845 
NOT COMPLETED   6 
Other                6 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants 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.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 851 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 46.2  (13.2) 
[1] Out of 851 participants, data for the baseline measure, age, was available only for 849 participants.
Gender, Customized 
[Units: Participants]
 
Female   528 
Male   322 
Not available   1 


  Outcome Measures

1.  Primary:   Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)   [ Time Frame: Week 12 ]

2.  Secondary:   Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)   [ Time Frame: Week 12 ]

3.  Secondary:   Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Number of Participants With Residual Symptoms in Case of Non Remission   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Protocol did not indicate primary or secondary endpoints and designation of endpoints as primary or secondary endpoints was arbitrary.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



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