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A Study in Participants With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor

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ClinicalTrials.gov Identifier: NCT01185340
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: LY2216684
Drug: Placebo
Drug: SSRI

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The first 3 weeks of the study was a double-blind Confirmation Phase during which participants continued to receive their SSRI with adjunctive placebo. If randomization criteria were met, participants were randomized to adjunctive LY2216684 or adjunctive placebo. If criteria were not met, participants continued on placebo to maintain the blind.

Reporting Groups
  Description
Placebo + SSRI (Pre-randomized Participants) Placebo: Administered orally, once daily for 3 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
LY2216684 + SSRI (Randomized Participants) LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo + SSRI (Randomized Participants) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo + SSRI (Non-randomized Participants) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Participant Flow for 2 periods

Period 1:   Confirmation (CF) Phase, 3 Weeks
    Placebo + SSRI (Pre-randomized Participants)   LY2216684 + SSRI (Randomized Participants)   Placebo + SSRI (Randomized Participants)   Placebo + SSRI (Non-randomized Participants)
STARTED   1056   0   0   0 
Entered Discontinuation (DC) Phase   18 [1]   0   0   0 
COMPLETED   968 [2]   0   0   0 
NOT COMPLETED   88   0   0   0 
Adverse Event                24                0                0                0 
Lack of Efficacy                6                0                0                0 
Lost to Follow-up                5                0                0                0 
Physician Decision                2                0                0                0 
Protocol Violation                16                0                0                0 
Withdrawal by Subject                32                0                0                0 
Sponsor Decision                3                0                0                0 
[1] Participants who discontinued the CF Phase early had the option to enter the DC Phase.
[2] Participants who completed the CF Phase entered the Adjunctive Treatment (AT) Phase.

Period 2:   Adjunctive Treatment (AT) Phase, 8 Weeks
    Placebo + SSRI (Pre-randomized Participants)   LY2216684 + SSRI (Randomized Participants)   Placebo + SSRI (Randomized Participants)   Placebo + SSRI (Non-randomized Participants)
STARTED   0   230   219   519 
Entered Discontinuation (DC) Phase   0   206 [1]   204 [1]   483 [1] 
COMPLETED   0   195   186   458 
NOT COMPLETED   0   35   33   61 
Adverse Event                0                13                8                13 
Lack of Efficacy                0                4                7                4 
Lost to Follow-up                0                4                5                7 
Physician Decision                0                1                0                1 
Protocol Violation                0                5                2                5 
Withdrawal by Subject                0                8                8                24 
Sponsor Decision                0                0                3                7 
[1] Participants who completed the AT Phase or discontinued early had the option to enter the DC Phase.



  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.
Participants who completed the Confirmation (CF) Phase and were randomized to adjunctive LY2216684 or adjunctive placebo or who did not met randomization criteria and continued on placebo to maintain the blind.

Reporting Groups
  Description
LY2216684 + SSRI (Randomized Participants) LY2216684: 12 or 18 milligrams (mg), administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo + SSRI (Randomized Participants) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Placebo + SSRI (Non-randomized Participants) Placebo: Administered orally, once daily for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
Total Total of all reporting groups

Baseline Measures
   LY2216684 + SSRI (Randomized Participants)   Placebo + SSRI (Randomized Participants)   Placebo + SSRI (Non-randomized Participants)   Total 
Overall Participants Analyzed 
[Units: Participants]
 230   219   519   968 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.29  (11.90)   48.44  (11.39)   47.39  (12.68)   47.84  (12.21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      155  67.4%      145  66.2%      354  68.2%      654  67.6% 
Male      75  32.6%      74  33.8%      165  31.8%      314  32.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      19   8.3%      12   5.5%      31   6.0%      62   6.4% 
Not Hispanic or Latino      164  71.3%      158  72.1%      370  71.3%      692  71.5% 
Unknown or Not Reported      47  20.4%      49  22.4%      118  22.7%      214  22.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      3   0.6%      3   0.3% 
Asian      2   0.9%      1   0.5%      3   0.6%      6   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      17   7.4%      31  14.2%      53  10.2%      101  10.4% 
White      207  90.0%      185  84.5%      457  88.1%      849  87.7% 
More than one race      4   1.7%      2   0.9%      2   0.4%      8   0.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   0.2%      1   0.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   93   89   195   377 
Belgium   7   4   13   24 
Austria   10   10   25   45 
Australia   22   20   84   126 
Germany   58   63   95   216 
United Kingdom   19   15   30   64 
Sweden   21   18   77   116 


  Outcome Measures

1.  Primary:   Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Randomization, 8 weeks ]

2.  Secondary:   Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Global Functional Impairment Score   [ Time Frame: Randomization, 8 weeks ]

3.  Secondary:   Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Impact Subscale Score   [ Time Frame: Randomization, 8 weeks ]

4.  Secondary:   Probability of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 at Week 8   [ Time Frame: 8 weeks ]

5.  Secondary:   Percentage of Participants Achieving a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of Less Than or Equal to 10 for at Least 2 Consecutive Measurements, Including the Participant's Last Measurement   [ Time Frame: Randomization up to 8 weeks ]

6.  Secondary:   Change From Randomization to Week 8 in Hospital and Anxiety and Depression Scale (HADS) Anxiety Subscale Score   [ Time Frame: Randomization, 8 weeks ]

7.  Secondary:   Probability of Participants Who Have a Greater Than or Equal to 50 Percent Improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8   [ Time Frame: 8 weeks ]

8.  Secondary:   Change From Randomization to Week 8 in The Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score   [ Time Frame: Randomization, 8 weeks ]

9.  Secondary:   Change From Randomization to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Individual Items   [ Time Frame: Randomization, 8 weeks ]

10.  Secondary:   Change From Randomization to Week 8 in Clinical Global Impressions of Severity (CGI-S)   [ Time Frame: Randomization, 8 weeks ]

11.  Secondary:   Change From Randomization to Week 8 in Fatigue Associated With Depression (FAsD) Average Score and Experience Subscale Score   [ Time Frame: Randomization, 8 weeks ]

12.  Secondary:   Change From Randomization to Week 8 in Sheehan Disability Scale (SDS) Items   [ Time Frame: Randomization, 8 weeks ]

13.  Secondary:   Change From Randomization to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)   [ Time Frame: Randomization, 8 weeks ]

14.  Secondary:   Change From Randomization to Week 8 in the EuroQol Questionnaire-5 Dimension (EQ-5D)   [ Time Frame: Randomization, 8 weeks ]

15.  Secondary:   Percentage of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Randomization up to 8 weeks ]

16.  Secondary:   Change From Randomization to Week 8 in Arizona Sexual Experiences (ASEX) Scale   [ Time Frame: Randomization, 8 weeks ]

17.  Secondary:   Change From Randomization to Week 8 in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)   [ Time Frame: Randomization, 8 weeks ]

18.  Secondary:   Change From Randomization to Week 8 in Blood Pressure   [ Time Frame: Randomization, 8 weeks ]

19.  Secondary:   Change From Randomization to Week 8 in Pulse Rate   [ Time Frame: Randomization, 8 weeks ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01185340     History of Changes
Other Study ID Numbers: 12183
H9P-MC-LNBR ( Other Identifier: Eli Lilly and Company )
First Submitted: August 18, 2010
First Posted: August 19, 2010
Results First Submitted: February 17, 2018
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018