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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: November 10, 2014
Last verified: November 2014
Results First Received: November 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: SPD489 (Lisdexamfetamine dimesylate )
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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  
Number of Participants  
[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 ]

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

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

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

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

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

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

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

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 ]

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

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

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


  Serious Adverse Events


  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


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01436149     History of Changes
Other Study ID Numbers: SPD489-322, 2011-003018-17
Study First Received: September 15, 2011
Results First Received: November 10, 2014
Last Updated: November 10, 2014
Health Authority: United States: Food and Drug Administration