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A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed Dose Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder (orvepitant MDD)

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ClinicalTrials.gov Identifier: NCT00880399
Recruitment Status : Terminated (To allow assessment of isolated events of seizure during program)
First Posted : April 13, 2009
Results First Posted : September 12, 2017
Last Update Posted : September 12, 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: orvepitant
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
This study was conducted at 20 centers across the United States of America (USA) (17 centers) and Canada (3 centers) from 04 March 2009 to 16 June 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 787 participants were screened for study eligibility, of which 331 participants were randomized. Out of 331 participants, 3 did not receive the study medication. All subjects population included all participants who had received at least one dose of the study medication and comprised of 328 participants.

Reporting Groups
  Description
Placebo Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Orvepitant 30 mg Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Orvepitant 60 mg Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.

Participant Flow:   Overall Study
    Placebo   Orvepitant 30 mg   Orvepitant 60 mg
STARTED   108   113   107 
COMPLETED   77   84   81 
NOT COMPLETED   31   29   26 
Adverse Event                4                6                5 
Lack of Efficacy                1                4                2 
Protocol Violation                4                4                6 
Study closed/terminated                3                7                4 
Lost to Follow-up                8                5                3 
Physician Decision                5                0                3 
Withdrawal by Subject                6                3                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 Participants received Orvepitant matching placebo tablets via oral route, once daily in the evening, for a total of 6 weeks.
Orvepitant 30 mg Participants received Orvepitant 30 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Orvepitant 60 mg Participants received Orvepitant 60 mg tablets via oral route, once daily in the evening, for a total of 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Orvepitant 30 mg   Orvepitant 60 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   113   107   328 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.7  (11.67)   41.0  (11.45)   38.2  (11.15)   39.7  (11.45) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      76  70.4%      68  60.2%      70  65.4%      214  65.2% 
Male      32  29.6%      45  39.8%      37  34.6%      114  34.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      1   0.9%      1   0.9%      2   1.9%      4   1.2% 
Asian      4   3.7%      2   1.8%      3   2.8%      9   2.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      16  14.8%      17  15.0%      21  19.6%      54  16.5% 
White      86  79.6%      92  81.4%      79  73.8%      257  78.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   0.9%      1   0.9%      2   1.9%      4   1.2% 


  Outcome Measures

1.  Primary:   Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) Total Score   [ Time Frame: Baseline (Day 1) to Week 6 ]

2.  Secondary:   Percentage of Participants With a >= 50 Percent (%) Reduction From Baseline in HAM-D Total Score   [ Time Frame: Baseline (Day 1) to Week 6 ]

3.  Secondary:   Number of Participants With (Maintained) Clinical Response   [ Time Frame: Up to Week 6 ]

4.  Secondary:   Change From Baseline in the Bech Melancholia Scale Total Score (Sum of Items 1, 2, 7, 8, 10, and 13 of the 17-item HAMD Scale)   [ Time Frame: Baseline (Day 1) to Week 6 ]

5.  Secondary:   Change From Baseline in the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR 16) Total Score   [ Time Frame: Baseline (Day 1) to Week 6 ]

6.  Secondary:   Change From Baseline in the HAM-D Anxiety Factor Score (Sum of Items 10, 11, 12, 13, 15 and 17)   [ Time Frame: Baseline (Day 1) to Week 6 ]

7.  Secondary:   Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved)   [ Time Frame: Up to Week 6 ]

8.  Secondary:   Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score   [ Time Frame: Baseline (Day 1) to Week 6 ]

9.  Secondary:   Change From Baseline in the Cognitive and Physical Function Questionnaire (CPFQ) Total Score   [ Time Frame: Baseline (Day 1) and Week 6 ]

10.  Secondary:   Change From Baseline in Morning Sleep Questionnaire (MSQ) Values for Total Sleep Time (TST), Sleep Onset Latency (SOL) and Wake Time After Sleep Onset (WTSO)   [ Time Frame: Baseline (Day 1) to Week 6 ]

11.  Secondary:   Change From Baseline in MSQ Values for Number of Nocturnal Awakenings   [ Time Frame: Baseline (Day 1) to Week 6 ]

12.  Secondary:   Change From Baseline in MSQ Values for Sleep Quality (SQ) and Refreshing Value of Sleep (RVS)   [ Time Frame: Baseline (Day 1) to Week 6 ]

13.  Secondary:   Number of Participants Who Remit (Have an Endpoint HAM-D Total Score <= 7) Who Continue to Show Symptoms on the HAM-D Sleep Items   [ Time Frame: Up to Week 6 ]

14.  Secondary:   Number of Participants With Suicidal Behavior, Ideation, and Most Common Ideation Using the Columbia Suicidality Severity Rating Scale (C-SSRS)   [ Time Frame: Week 8 ]

15.  Secondary:   Number of Discontinuation-emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)   [ Time Frame: Week 1 to Week 8/Follow up 1 ]

16.  Secondary:   Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ)-Males   [ Time Frame: Baseline (Day 1) to Week 6 ]

17.  Secondary:   Change From Baseline in the MSFQ Total Score-Females   [ Time Frame: Baseline (Day 1) to 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
The study was terminated early upon recommendation of IDMC that was reviewing data from this trial and two other ongoing trials with same drug. When the trial was terminated 331 participants were randomized, compared to a target of 348 participants.


  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:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00880399     History of Changes
Other Study ID Numbers: 111733
First Submitted: April 9, 2009
First Posted: April 13, 2009
Results First Submitted: April 20, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017