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Trial record 29 of 398 for:    depression AND Major Depression AND HAM- | "Depression"

A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder (Orvepitant MDD)

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ClinicalTrials.gov Identifier: NCT00880048
Recruitment Status : Terminated (To allow assessment of isolated events of seizure during program)
First Posted : April 13, 2009
Results First Posted : October 13, 2017
Last Update Posted : October 13, 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
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
The study was conducted at 31 centers across the North America (27 centers in United States of America and 4 centers in Canada) during the period 06 April 2009 to 21 June 2010. Total of 1604 participants were screened for study eligibility, of which 343 participants were randomized into the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 339 participants were included in Intent-to-treat (ITT) population. ITT population comprised of all participants who gave informed consent, were randomized, received at least one dose of double blind medication and for whom at least one post-randomization assessment was available.

Reporting Groups
  Description
Placebo Participants received one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
GW823296 30 mg Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
GW823296 60 mg Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.

Participant Flow:   Overall Study
    Placebo   GW823296 30 mg   GW823296 60 mg
STARTED   116   115   112 
COMPLETED   88   82   77 
NOT COMPLETED   28   33   35 
Adverse Event                2                3                5 
Lack of Efficacy                1                2                2 
Protocol Violation                4                6                5 
Lost to Follow-up                6                6                5 
Physician Decision                1                1                7 
Withdrawal by Subject                5                8                5 
Study closed/terminated                9                7                6 



  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 one tablet of matching placebo, once daily, in the evening for a period of 6 weeks.
GW823296 30 mg Participants received one tablet of GW823296 (orvepitant) 30 milligrams (mg), once daily, in the evening for a period of 6 weeks.
GW823296 60 mg Participants received one tablet of GW823296 (orvepitant) 60 mg, once daily, in the evening for a period of 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   GW823296 30 mg   GW823296 60 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   115   112   343 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.7  (10.61)   40.4  (11.35)   43.1  (10.66)   41.7  (10.90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      68  58.6%      75  65.2%      73  65.2%      216  63.0% 
Male      48  41.4%      40  34.8%      39  34.8%      127  37.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1   0.9%      0   0.0%      1   0.3% 
Asian      3   2.6%      3   2.6%      1   0.9%      7   2.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      1   0.9%      0   0.0%      1   0.3% 
Black or African American      32  27.6%      24  20.9%      33  29.5%      89  25.9% 
White      78  67.2%      83  72.2%      76  67.9%      237  69.1% 
More than one race      2   1.7%      2   1.7%      2   1.8%      6   1.7% 
Unknown or Not Reported      1   0.9%      1   0.9%      0   0.0%      2   0.6% 


  Outcome Measures

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

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

3.  Secondary:   Number of Participants Who Maintained Clinical Response by Week 6   [ 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 HAM-D Scale)   [ Time Frame: Baseline and up 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 and up 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 and up to Week 6 ]

7.  Secondary:   Percentage of Participants With Clinical Global Impression- Global Improvement (CGI-I) Score   [ 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 and up to Week 6 ]

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

10.  Secondary:   Change From Baseline in Morning Sleep Questionnaire (MSQ) Total Sleep Time, Sleep Onset Latency and Wake Time After Sleep Onset   [ Time Frame: Baseline and up to Week 6 ]

11.  Secondary:   Change From Baseline in the MSQ Number of Nocturnal Awakenings   [ Time Frame: Baseline and upto Week 6 ]

12.  Secondary:   Change From Baseline in the MSQ Sleep Quality and Refreshing Value of Sleep   [ Time Frame: Baseline and up to Week 6 ]

13.  Secondary:   Number of HAM-D Remitters   [ Time Frame: Up to Week 6 ]

14.  Secondary:   Number of Participants With Suicide-Related Events Based on the Columbia Suicidality Severity Rating Scale (CSSRS)   [ Time Frame: Up to 17 days post-treatment ]

15.  Secondary:   Number of Incidences of Discontinuation Emergent Signs and Symptoms Using the Discontinuation-Emergent Signs and Symptoms (DESS)   [ Time Frame: Up to 17 days post-treatment ]

16.  Secondary:   Change From Baseline in the Massachusetts Sexual Function Questionnaire (MSFQ) Total Score in Males   [ Time Frame: Baseline and up to Week 6 ]

17.  Secondary:   Change From Baseline in the MSFQ Total Score in Females   [ Time Frame: Baseline and up 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 the recommendation of an Independent Data Monitoring Committee. At the time the trial was terminated 343 participants had been 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: NCT00880048     History of Changes
Other Study ID Numbers: 110833
First Submitted: April 9, 2009
First Posted: April 13, 2009
Results First Submitted: August 9, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017