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SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01435759
First received: September 15, 2011
Last updated: February 3, 2015
Last verified: February 2015
History of Changes
Results First Received: February 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Drug: Antidepressant + Placebo

  Participant Flow
  Hide 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
No text entered.

Reporting Groups
  Description
Antidepressant + Single-blind Placebo Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
Antidepressant + Double-blind Placebo Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
Antidepressant + Double-blind SPD489 10mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
Antidepressant + Double-blind SPD489 30mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
Antidepressant + Double-blind SPD489 50mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
Antidepressant + Double-blind SPD489 70mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.

Participant Flow for 2 periods

 Period 1:   Antidepressant Lead-in Phase
    Antidepressant + Single-blind Placebo   Antidepressant + Double-blind Placebo   Antidepressant + Double-blind SPD489 10mg   Antidepressant + Double-blind SPD489 30mg   Antidepressant + Double-blind SPD489 50mg   Antidepressant + Double-blind SPD489 70mg
STARTED   1197 [1]   0   0   0   0   0 
COMPLETED   855   0   0   0   0   0 
NOT COMPLETED   342   0   0   0   0   0 
Adverse Event                40                0                0                0                0                0 
Protocol Violation                16                0                0                0                0                0 
Withdrawal by Subject                74                0                0                0                0                0 
Lost to Follow-up                83                0                0                0                0                0 
Met BP or Pulse Withdrawal Criteria                10                0                0                0                0                0 
Not Specified                119                0                0                0                0                0 
[1] Of these 1197 subjects, 19 subjects were not dosed.

Period 2:   Double-blind Phase
    Antidepressant + Single-blind Placebo   Antidepressant + Double-blind Placebo   Antidepressant + Double-blind SPD489 10mg   Antidepressant + Double-blind SPD489 30mg   Antidepressant + Double-blind SPD489 50mg   Antidepressant + Double-blind SPD489 70mg
STARTED   463 [1]   78   78 [2]   78 [3]   78   80 
COMPLETED   397   71   71   69   69   71 
NOT COMPLETED   66   7   7   9   9   9 
Adverse Event                7                0                1                1                1                3 
Protocol Violation                2                0                1                2                0                1 
Withdrawal by Subject                17                4                3                4                2                2 
Lost to Follow-up                31                1                2                0                3                3 
Met BP or Pulse Withdrawal Criteria                1                0                0                0                3                0 
Not Specified                8                2                0                2                0                0 
[1] These subjects were not included in the Safety Dose Response Evaluable Set or Safety Analysis Set.
[2] One subject was not dosed.
[3] Two subjects were not dosed.



  Baseline Characteristics
  Hide 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.
Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 post-augmentation baseline safety assessment (e.g. coming back for any visit, reporting of an adverse event [AE] or reporting the absence of AEs). Subjects who received only single-blind placebo were not included in this group.

Reporting Groups
  Description
Antidepressant + Double-blind Placebo Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
Antidepressant + Double-blind SPD489 10mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
Antidepressant + Double-blind SPD489 30mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
Antidepressant + Double-blind SPD489 50mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
Antidepressant + Double-blind SPD489 70mg Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
Total Total of all reporting groups

Baseline Measures
   Antidepressant + Double-blind Placebo   Antidepressant + Double-blind SPD489 10mg   Antidepressant + Double-blind SPD489 30mg   Antidepressant + Double-blind SPD489 50mg   Antidepressant + Double-blind SPD489 70mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 78   77   76   78   80   389 
Age 
[Units: Years]
Mean (Standard Deviation) 		 43.7  (10.48)   39.1  (11.83)   43.4  (12.06)   43.8  (12.4)   41.5  (10.81)   42.3  (11.61) 
Age, Customized 
[Units: Participants]
 		           
18-55   69   70   62   60   71   332 
56-65   9   7   14   18   9   57 
Gender 
[Units: Participants]
 		           
Female   53   53   52   53   53   264 
Male   25   24   24   25   27   125 
Region of Enrollment 
[Units: Participants]
 		           
ARGENTINA   2   3   5   3   5   18 
AUSTRALIA   0   0   0   2   3   5 
CHILE   3   6   12   9   2   32 
UNITED KINGDOM   1   0   0   0   0   1 
UNITED STATES   72   68   59   64   70   333 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)   [ Time Frame: Augmentation Baseline (Week 8) to Week 16 ]
  Show Outcome Measure 1

2.  Secondary:   Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16   [ Time Frame: From Augmentation Baseline (Week 8) to Week 16 ]
  Show Outcome Measure 2

3.  Secondary:   Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16   [ Time Frame: From Augmentation Baseline (Week 8) to Week 16 ]
  Show Outcome Measure 3

4.  Secondary:   Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16   [ Time Frame: From Augmentation Baseline (Week 8) to Week 16 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Study Physician
Organization: Shire
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01435759     History of Changes
Other Study ID Numbers: SPD489-209
2011-003615-28 ( EudraCT Number )
Study First Received: September 15, 2011
Results First Received: February 3, 2015
Last Updated: February 3, 2015