ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study to Test a New Drug to Treat Major Depression (PKI113009)

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: NCT00976560
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: GW856553
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted between 25 Sep 2009 to 7 July 2010. The study was conducted at 21 centers in 5 countries (Bulgaria [4], Estonia [1], Germany [7], Russia [5], United States [4]).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 128 participants of both the gender, with major depressive disorder (MDD), having at least one previous major depressive episode in history and currently undergoing a recurrence, of age group 18 to 60, were enrolled globally. A total of 231 participants were screened of which 103 were screen-failures.

Reporting Groups
  Description
Placebo Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
GW856553 7.5 mg BID Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.

Participant Flow:   Overall Study
    Placebo   GW856553 7.5 mg BID
STARTED   64   64 
COMPLETED   50   51 
NOT COMPLETED   14   13 
Adverse Event                5                5 
Lack of Efficacy                3                5 
Protocol Violation                1                0 
Lost to Follow-up                1                0 
Physician Decision                2                0 
Withdrawal by Subject                2                3 



  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
Placebo Eligible participants received matching placebo, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
GW856553 7.5 mg BID Eligible participants received GW856553 7.5 mg, orally, twice daily with food at morning and evening with the interval of 12 hours for 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   GW856553 7.5 mg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   64   128 
Age, Customized 
[Units: Participants]
Count of Participants
     
18 to 60 years   64   64   128 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37  57.8%      39  60.9%      76  59.4% 
Male      27  42.2%      25  39.1%      52  40.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.6%      0   0.0%      1   0.8% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   4.7%      1   1.6%      4   3.1% 
White      60  93.8%      63  98.4%      123  96.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Change From Randomization (Week 0) Associated With GW856553 Versus Placebo at Week 6 in the Bech (6-item HAMD-17 [Hamilton Depression Rating Scale]) Score.   [ Time Frame: At Week 6 ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 6 Weeks ]

3.  Secondary:   Number of Participants With Suicidality as Assessed by the Columbia Suicidality Severity Rating Scale Score   [ Time Frame: Upto Week 6 ]

4.  Secondary:   Number of Participants With Abnormal Haematology and Clinical Chemistry Values   [ Time Frame: Upto Week 6 ]

5.  Secondary:   Number of Participants With Abnormal Vital Signs (Blood Pressure, Heart Rate)   [ Time Frame: Up to follow-up Visit (Day 53) ]

6.  Secondary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings   [ Time Frame: Up to follow-up Visit (Day 53) ]

7.  Secondary:   Changes From Randomization (Week 0)in IL-6 and TNF-alpha Associated With GW856553 Versus Placebo at Week 1 and Week 6 in the Morning Plasma Levels   [ Time Frame: Upto Week 6 ]

8.  Secondary:   Change From Randomisation Bech Total Score: Bech Score   [ Time Frame: Up to Follow-up visit (Day 53) ]

9.  Secondary:   Mean HAMD-17 Total Score   [ Time Frame: Up to Follow-up visit (Day 53) ]

10.  Secondary:   Mean Inventory of Depressive Symptomatology Clinician (IDS-C) Total Score   [ Time Frame: Up to Follow-up visit (Day 53) ]

11.  Secondary:   Mean IDS-SR Total Score   [ Time Frame: Up to Week 6 ]

12.  Secondary:   Mean Quick Inventory of Depressive Symptomatology Self Report-16 Item (QIDS-SR16) Total Score Derived From the IDS-SR (Only at Weeks 0, 2, 4 and 6)   [ Time Frame: Weeks 0, 2, 4 and 6 ]

13.  Secondary:   Percentage of IDS-C Responders (Participants With a Reduction in Total Score of ≥50% From Randomization at Week 6/Study Exit).   [ Time Frame: Week 6 ]

14.  Secondary:   Percentage of IDS-C Remitters (Participants Whose Total Score Was ≤ 15 at Week 6/Study Exit).   [ Time Frame: Week 6 ]

15.  Secondary:   Percentage of IDS-SR Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).   [ Time Frame: Week 6 ]

16.  Secondary:   Percentage of IDS-SR Remitters (Participants Whose Total Score Was ≤ 15 at Week 6/Study Exit).   [ Time Frame: Week 6 ]

17.  Secondary:   Percentage of QIDS-SR16 Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).   [ Time Frame: Week 6 ]

18.  Secondary:   Percentage of QIDS-SR16 Remitters (Subjects Whose Total Score Was ≤ 5 at Week 6/Study Exit).   [ Time Frame: Week 6 ]

19.  Secondary:   Percentage of Bech Responders (Participants With a Reduction in Total Score of ≥ 50% From Randomization at Week 6/Study Exit).   [ Time Frame: Week 6 ]

20.  Secondary:   Percentage of Bech Remitters (Participants Whose Total Score Was ≤ 4 at Week 6/Study Exit).   [ Time Frame: Week 6 ]

21.  Secondary:   Percentage of Participants With a Clinicians Global Impression of Improvement (CGI-I) Score of 1 ("Very Much Improved") or 2 ("Much Improved") at Weeks 1, 2, 3, 4, 5 and 6.   [ Time Frame: Weeks 1, 2, 3, 4, 5 and 6 ]

22.  Secondary:   Assessment of Clinical Global Impression-Severity of Illness (CGI-S) up to 6 Weeks   [ Time Frame: Upto Week 6 ]


  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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00976560     History of Changes
Other Study ID Numbers: 113009
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: August 14, 2017
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017