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Efficacy and Safety Study of 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:
NCT01436149
First received: September 15, 2011
Last updated: April 13, 2015
Last verified: November 2014
History of Changes
Results First Received: November 10, 2014  
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: SPD489 (Lisdexamfetamine dimesylate )
Drug: 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 oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended-release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
Antidepressant + Double-blind Placebo Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
Antidepressant + Double-blind SPD489 Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose).

Participant Flow for 2 periods

 Period 1:   Antidepressant Lead-in Phase
    Antidepressant + Single-blind Placebo   Antidepressant + Double-blind Placebo   Antidepressant + Double-blind SPD489
STARTED   1262 [1]   0   0 
COMPLETED   896   0   0 
NOT COMPLETED   366   0   0 
Adverse Event                39                0                0 
Protocol Violation                29                0                0 
Withdrawal by Subject                61                0                0 
Lost to Follow-up                96                0                0 
Met BP Or Pulse Withdrawal Criteria                22                0                0 
Not Specified                119                0                0 
[1] Twenty-three subjects were enrolled but not dosed.

Period 2:   Randomized Phase
    Antidepressant + Single-blind Placebo   Antidepressant + Double-blind Placebo   Antidepressant + Double-blind SPD489
STARTED   492 [1]   202 [2]   202 [2] 
COMPLETED   415   164   160 [3] 
NOT COMPLETED   77   38   42 
Adverse Event                9                10                11 
Protocol Violation                4                5                0 
Withdrawal by Subject                16                10                10 
Lost to Follow-up                34                5                6 
Lack of Efficacy                0                0                1 
Met BP Or Pulse Withdrawal Criteria                2                3                3 
Not Specified                12                5                11 
[1] These subjects were not included in the Safety Analysis Set or Full Analysis Set.
[2] One subject did not receive at least 1 dose of double-blind treatment.
[3] 1 subject completed the study without a Visit 14 MADRS and was not included in the completers set.



  Baseline Characteristics
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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 safety assessment (e.g., coming back for any visit, reporting of an adverse event [AE], or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).

Reporting Groups
  Description
Antidepressant + Double-blind Placebo Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
Antidepressant + Double-blind SPD489 Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose) for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Antidepressant + Double-blind Placebo   Antidepressant + Double-blind SPD489   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 201   201   402 
Age 
[Units: Years]
Mean (Standard Deviation) 		 41.8  (12.04)   42.2  (12.32)   42  (12.17) 
Age, Customized 
[Units: Participants]
 		     
18-55 years   173   170   343 
56-65 years   28   31   59 
Gender 
[Units: Participants]
 		     
Female   133   129   262 
Male   68   72   140 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks   [ Time Frame: 8 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks   [ Time Frame: 8 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Achieving a 25% Response on the MADRS   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants Achieving a 50% Response on the MADRS   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants Achieving Remission on the MADRS   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Mean Change From Baseline Over Time in MADRS Total Score   [ Time Frame: Baseline and up to 8 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Clinical Global Impressions - Global Improvement (CGI-I)   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Columbia Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Amphetamine Cessation Symptom Assessment (ACSA)   [ Time Frame: up to 8 weeks ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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  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: NCT01436149     History of Changes
Other Study ID Numbers: SPD489-322
2011-003018-17 ( EudraCT Number )
Study First Received: September 15, 2011
Results First Received: November 10, 2014
Last Updated: April 13, 2015