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A Study for Participants With Major Depression

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ClinicalTrials.gov Identifier: NCT00420004
Recruitment Status : Completed
First Posted : January 9, 2007
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: LY2216684
Drug: Placebo
Drug: Escitalopram

  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
A total of 701 participants were included in a screening/washout period (from 3 to 30 days in duration) prior to group assignments; 232 participants discontinued during this period, and 469 participants were randomized. There was an 8-week Double-blind Phase followed by a 1-week Discontinuation Phase after abrupt discontinuation of treatment.

Reporting Groups
  Description
LY2216684 LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
Placebo Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
Escitalopram Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks

Participant Flow:   Overall Study
    LY2216684   Placebo   Escitalopram
STARTED   269   138   62 
Received at Least 1 Dose of Study Drug   249 [1]   122 [1]   54 [1] 
COMPLETED   140   67   30 
NOT COMPLETED   129   71   32 
Adverse Event                4                1                1 
Lack of Efficacy                5                4                1 
Lost to Follow-up                31                12                10 
Entry Criteria Not Met                0                1                0 
Physician Decision                14                4                2 
Protocol Violation                5                4                3 
Withdrawal by Subject                67                42                14 
Sponsor Decision                3                3                1 
[1] Participants who received >=1 dose of study drug and had baseline and post-baseline data available



  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.
All randomized participants.

Reporting Groups
  Description
LY2216684 LY2216684: flexible dose of 3, 6, 9, or 12 milligrams (mg), tablets, administered orally, once daily for 8 weeks
Placebo Placebo: tablet and capsule equivalents to LY2216684 and escitalopram, respectively, administered orally, once daily for 8 weeks
Escitalopram Escitalopram: flexible dose of 10 or 20 mg, capsules, administered orally, once daily for 8 weeks
Total Total of all reporting groups

Baseline Measures
   LY2216684   Placebo   Escitalopram   Total 
Overall Participants Analyzed 
[Units: Participants]
 269   138   62   469 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.64  (10.21)   37.54  (10.97)   34.32  (9.66)   36.60  (10.40) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female   130   65   22   217 
Male   139   73   40   252 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Caucasian   30   21   8   59 
African   6   5   0   11 
Hispanic   23   7   4   34 
Native American   1   0   0   1 
West Asian (Indian subcontinent)   209   105   50   364 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   39   23   8   70 
Romania   7   4   1   12 
India   208   105   50   363 
Mexico   15   6   3   24 


  Outcome Measures

1.  Primary:   Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score   [ Time Frame: Baseline, Week 8 ]

2.  Secondary:   Change From Baseline to Week 8 in Maier-Philipp Subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17)   [ Time Frame: Baseline, Week 8 ]

3.  Secondary:   Response and Remission Rates   [ Time Frame: Baseline, up to Week 8 ]

4.  Secondary:   Clinical Global Impression of Improvement Score at Week 8   [ Time Frame: Week 8 ]

5.  Secondary:   Change From Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

6.  Secondary:   Change From Baseline on the 36-item Short-Form (SF-36) Health Status Survey Mental and Physical Components up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

7.  Secondary:   Change From Baseline in Quick Inventory of Depressive Symptomatology Total Score up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

8.  Secondary:   Change From Baseline in Beck Scale for Suicide Ideation up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

9.  Secondary:   Change From Baseline in Modified Overt Aggression (OAS-M) Scale up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

10.  Secondary:   Change From Baseline in Arizona Sexual Experiences Scale up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

11.  Secondary:   Change From Baseline in Insomnia Severity Index up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

12.  Secondary:   Change From Baseline to Week 8 in Fatigue Severity Scale   [ Time Frame: Baseline, Week 8 ]

13.  Secondary:   Pharmacokinetics: Predicted Maximal Concentration of LY2216684 at Steady State (Cmax,ss) at Week 8 Endpoint   [ Time Frame: Up to 8 weeks ]

14.  Secondary:   Number of Participants With at Least 1 Serious Adverse Event (Safety and Tolerability)   [ Time Frame: Baseline through Week 8 ]

15.  Secondary:   Change From Baseline to Week 8 in the 21-item Hamilton Depression Rating Scale (HAM-21) Total Score   [ Time Frame: Baseline, Week 8 ]

16.  Secondary:   Cognitive Assessment Battery: Change From Baseline in Word List Learning and Delayed Recall Test (WLDRT) up to Week 8 Endpoint   [ Time Frame: Baseline, up to week 8 ]

17.  Secondary:   Cognitive Assessment Battery: Change From Baseline in Symbol Digit Substitution Test (SDST) up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

18.  Secondary:   Cognitive Assessment Battery: Change From Baseline in Two Digit Cancellation Test up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 8 ]

19.  Secondary:   Cognitive Assessment Battery: Change From Baseline in Trail Making A up to Week 8 Endpoint   [ Time Frame: Baseline, up to Week 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 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



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00420004     History of Changes
Other Study ID Numbers: 11174
H9P-MC-LNBD ( Other Identifier: Eli Lilly and Company )
First Submitted: January 5, 2007
First Posted: January 9, 2007
Results First Submitted: February 17, 2018
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018