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A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00733980
Recruitment Status : Completed
First Posted : August 13, 2008
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Interventions: Drug: GSK561679
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
A total of 150 female participants, with major depressive disorder (MDD), were randomized in the study. The study was conducted from 02 October 2008 to 18 June 2010 at 18 centers across the United States.

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
GSK561679 The participants in this arm received GSK561679, 350 milligram (mg) orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks.
Placebo The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening.

Participant Flow:   Overall Study
    GSK561679   Placebo
STARTED   74   76 
COMPLETED   52   55 
NOT COMPLETED   22   21 
Adverse Event                5                2 
Lack of Efficacy                0                1 
Protocol Violation                2                1 
Protocol defined stopping criteria reach                1                1 
Lost to Follow-up                6                11 
Physician Decision                2                3 
Withdrawal by Subject                6                2 



  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
GSK561679 The participants in this arm received GSK561679, 350 mg orally daily as 3x100 mg tablets plus one 50 mg tablet in evening, for 6-weeks
Placebo The participants in this arm received matching placebo, and took orally as 4 placebo tablets once daily in the evening
Total Total of all reporting groups

Baseline Measures
   GSK561679   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 74   76   150 
Age 
[Units: Years]
Mean (Standard Deviation) 		 38.8  (11.31)   40.8  (12.17)   39.8  (11.76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      74 100.0%      76 100.0%      150 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
American Indian or Alaska Native      0   0.0%      2   2.6%      2   1.3% 
Asian      0   0.0%      1   1.3%      1   0.7% 
Native Hawaiian or Other Pacific Islander      1   1.4%      0   0.0%      1   0.7% 
Black or African American      43  58.1%      38  50.0%      81  54.0% 
White      30  40.5%      35  46.1%      65  43.3% 
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 to the End of Treatment Phase (Week 6) in the Bech Melancholia Subscale (Bech) (Items 1, 2, 7, 8, 10 and 13) From the Hamilton Rating Scale for Depression (HamD17).   [ Time Frame: Randomization (Week 0) and Week 6 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Randomization to Weeks 1, 2, and 4 in the Bech Melancholia Scale Score.   [ Time Frame: Randomization (Week 0) and Week 1, 2 and 4 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Anxiety Scale (HAM A)   [ Time Frame: Randomization (Week 0) and Week 1, 2, 4 and Week 6 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Randomization to Weeks 1, 2, 3, 4, and 6 in the Inventory of Depressive Symptomatology-Self- Report (IDS-SR) Total Score.   [ Time Frame: Randomization (Week 0) and Week 1, 2, 3,4 and Week 6 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Randomization to Weeks 1, 2, 4, and 6 in the Hamilton Rating Scale for Depression (HAMD-17)   [ Time Frame: Randomization (Week 0) and Week 1, 2, 4 and Week 6 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage HAMD-17 Responders at Weeks 1, 2, 4, and 6.   [ Time Frame: Weeks 1, 2, 4, and 6. ]
  Show Outcome Measure 6

7.  Secondary:   Time to Maintained Antidepressant Response at the End of Treatment Phase (Week 6)   [ Time Frame: Week 6 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Randomization in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 4, and 6.   [ Time Frame: Randomization (Week 0) and Weeks 1, 2, 4, and 6. ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Clinical Global Impression - Global Improvement (CGI-I) Responders at Weeks 1, 2, 4, and 6.   [ Time Frame: Weeks 1, 2, 4, and 6. ]
  Show Outcome Measure 9

10.  Secondary:   Change From Randomization in the Medical Outcomes Study 12-item Sleep Module (MOS 12) at Week 6   [ Time Frame: Randomization (Week 0) and Week 6 ]
  Show Outcome Measure 10

11.  Secondary:   Change From Randomization in the Cohen Perceived Stress Scale (PSS) at Week 6.   [ Time Frame: Randomization (Week 0) and Week 6. ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: Up to 28-day FU (18 months) ]
  Show Outcome Measure 12

13.  Secondary:   Number of Participants With Vital Sign of Potential Clinical Importance (PCI)   [ Time Frame: Up to Week 10 ]
  Show Outcome Measure 13

14.  Secondary:   Number of Participants With Abnormal Urinalysis Data   [ Time Frame: Randomization (Week 0), Week 3, Week 6/ Early withdrawal (EW) and 28 Day follow-up (FU) ]
  Show Outcome Measure 14

15.  Secondary:   Number of Participants With Abnormal Electrocardiograph (ECG) Values   [ Time Frame: Randomization (Week 0), Week 4, Week 6 and 28 Day follow-up ]
  Show Outcome Measure 15

16.  Secondary:   Number of Participants With Abnormal Hematology Values of PCI-Platelet   [ Time Frame: Upto 28-day FU ]
  Show Outcome Measure 16

17.  Secondary:   Number of Participants With Clinical Chemistry Laboratory Data Outside Reference Range   [ Time Frame: Upto Week 10 ]
  Show Outcome Measure 17

18.  Secondary:   Number of Participants With Hormonal Data of PCI   [ Time Frame: up to Week 10 ]
  Show Outcome Measure 18

19.  Secondary:   Discontinuation-Emergent Signs and Symptoms   [ Time Frame: At Week 6, 7-day (D) FU and 28-D FU ]
  Show Outcome Measure 19


  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


Publications:
GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00733980     History of Changes
Other Study ID Numbers: 106139
First Submitted: August 12, 2008
First Posted: August 13, 2008
Results First Submitted: August 29, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017