ClinicalTrials.gov
ClinicalTrials.gov Menu

A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

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: NCT01138007
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : May 6, 2013
Last Update Posted : August 10, 2018
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: 323U66 SR 150 mg tablet
Drug: 323U66 SR 150 mg placebo tablet

  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 572 participants were enrolled in the study; however, 3 of these participants were mistakenly registered and were not randomized to study treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who met the inclusion criteria enrolled in the 1- to 2-week Run-in Phase before entering the 8-week Treatment Phase, followed by the 2-week Follow-up Phase. In the Run-in Phase, the previous/existing prohibited medications administered were washed out, and participants' clinical symptoms were carefully monitored.

Reporting Groups
  Description
Placebo A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
323U66 SR 150 mg A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
323U66 SR 300 mg A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.

Participant Flow:   Overall Study
    Placebo   323U66 SR 150 mg   323U66 SR 300 mg
STARTED   187   190   192 
COMPLETED   165   160   144 
NOT COMPLETED   22   30   48 
Adverse Event                4                12                9 
Lack of Efficacy                2                0                6 
Protocol Violation                2                3                2 
Protocol-Defined Stopping Criteria                6                1                8 
Lost to Follow-up                3                3                5 
Physician Decision                0                5                3 
Withdrawal by Subject                5                6                15 



  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 A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
323U66 SR 150 mg A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
323U66 SR 300 mg A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
Total Total of all reporting groups

Baseline Measures
   Placebo   323U66 SR 150 mg   323U66 SR 300 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 186   190   188   564 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 37.9  (11.09)   36.0  (10.42)   37.5  (10.96)   37.1  (10.83) 
[1] Baseline data were collected in members of the Full Analysis Set (FAS), consisting of all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e., Week 1 or later).
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
       
Female      101  54.3%      98  51.6%      105  55.9%      304  53.9% 
Male      85  45.7%      92  48.4%      83  44.1%      260  46.1% 
[1] Baseline data were collected in members of the FAS, consisting of all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e., Week 1 or later).
Race/Ethnicity, Customized [1] 
[Units: Participants]
       
Asian – Japanese Heritage   149   154   147   450 
Asian – East Asian Heritage   37   36   40   113 
Asian – Mixed Race   0   0   1   1 
[1] Baseline data were collected in members of the FAS, consisting of all participants who took at least one dose of investigational product and provided at least one efficacy observation at a Treatment Phase visit (i.e., Week 1 or later).


  Outcome Measures

1.  Primary:   Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8/Withdrawal   [ Time Frame: Baseline and Week 8/Withdrawal ]

2.  Secondary:   Change From Baseline in the MADRS Total Score at Weeks 1, 2, 4, and 6   [ Time Frame: Baseline; Weeks 1, 2, 4, and 6 ]

3.  Secondary:   Change From Baseline in the MADRS Individual Item Scores at Weeks 1, 2, 4, 6, and 8   [ Time Frame: Baseline; Week 1, 2, 4, 6, and 8 ]

4.  Secondary:   Number of MADRS Responders at Week 8   [ Time Frame: Baseline and Week 8 ]

5.  Secondary:   Number of MADRS Remitters at Week 8   [ Time Frame: Week 8 ]

6.  Secondary:   Number of Clinical Global Impression-Global Improvement (CGI-GI) Responders at Week 8   [ Time Frame: Week 8 ]

7.  Secondary:   Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-SI) Scores at Weeks 1, 2, 4, 6, and 8   [ Time Frame: Baseline; Weeks 1, 2, 4, 6, and 8 ]

8.  Secondary:   Change From Baseline in the Inventory of Depressive Symptomatology-Self Report (IDS-SR) Total Score at Weeks 1, 2, 4, 6, and 8   [ Time Frame: Baseline; Weeks 1, 2, 4, 6, and 8 ]

9.  Secondary:   Change From Baseline in the IDS-SR Subscores for Energy, Pleasure, and Interest at Weeks 1, 2, 4, 6, and 8   [ Time Frame: Baseline; Weeks 1, 2, 4, 6, and 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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01138007     History of Changes
Other Study ID Numbers: 113351
First Submitted: June 3, 2010
First Posted: June 7, 2010
Results First Submitted: March 7, 2013
Results First Posted: May 6, 2013
Last Update Posted: August 10, 2018