ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Of Bupropion SR (323U66) In Patients With Major Depressive Disorder In Japan

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.
ClinicalTrials.gov Identifier: NCT00330616
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : March 20, 2009
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:
GlaxoSmithKline

Study Type: Interventional
Study Design: Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Major Depressive Disorder (MDD)
Intervention: Drug: 323U66 SR

  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
Bupropion SR Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.

Participant Flow:   Overall Study
    Bupropion SR
STARTED   35 
COMPLETED   14 
NOT COMPLETED   21 
Adverse Event                13 
Lack of Efficacy                1 
Lost to Follow-up                2 
Withdrawal by Subject                4 
Not specified                1 



  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
Bupropion SR No text entered.

Baseline Measures
   Bupropion SR 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.5  (5.08) 
Gender 
[Units: Participants]
 
Female   26 
Male   9 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian - Japanese Heritage   35 


  Outcome Measures

1.  Primary:   Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4   [ Time Frame: Baseline and Week 4 ]

3.  Secondary:   Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]

4.  Secondary:   Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4   [ Time Frame: Week 4 ]

5.  Secondary:   Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8   [ Time Frame: Week 8 ]

6.  Secondary:   Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4   [ Time Frame: Week 4 ]

7.  Secondary:   Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8   [ Time Frame: Week 8 ]

8.  Secondary:   Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4   [ Time Frame: Baseline and Week 4 ]

9.  Secondary:   Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8   [ Time Frame: Baseline and Week 8 ]

10.  Secondary:   Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4   [ Time Frame: Baseline and Week 4 ]

11.  Secondary:   Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8   [ Time Frame: Baseline and Week 8 ]

12.  Secondary:   Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]

13.  Secondary:   Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8   [ Time Frame: Week 4 and Week 8 ]

14.  Secondary:   Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8   [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 8 ]

15.  Secondary:   Adverse Events (>=5% Incidence)   [ Time Frame: Baseline through Week 8 ]

16.  Secondary:   Serious Adverse Events   [ Time Frame: Baseline through Week 8 ]


  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
No text entered.


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00330616     History of Changes
Other Study ID Numbers: AK1102369
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: November 26, 2008
Results First Posted: March 20, 2009
Last Update Posted: May 4, 2015