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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:
NCT01436162
First received: September 15, 2011
Last updated: November 6, 2014
Last verified: November 2014
History of Changes
Results First Received: October 31, 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: Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
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
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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 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 a 20, 30, 50, or 70 mg dose).
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).

Participant Flow for 2 periods

 Period 1:   Single-blind Lead-in Phase
    Antidepressant + Single-blind Placebo   Antidepressant + Double-blind SPD489   Antidepressant + Double-blind Placebo
STARTED   1105 [1]   0   0 
COMPLETED   823   0   0 
NOT COMPLETED   282   0   0 
Adverse Event                26                0                0 
Protocol Violation                24                0                0 
Withdrawal by Subject                69                0                0 
Lost to Follow-up                43                0                0 
Met BP or Pulse Withdrawal Criteria                13                0                0 
Not Specified                107                0                0 
[1] Ten subjects were enrolled but not dosed.

Period 2:   Randomized Phase
    Antidepressant + Single-blind Placebo   Antidepressant + Double-blind SPD489   Antidepressant + Double-blind Placebo
STARTED   397 [1]   212 [2]   214 [2] 
COMPLETED   353   181   189 
NOT COMPLETED   44   31   25 
Adverse Event                1                5                6 
Protocol Violation                4                4                2 
Withdrawal by Subject                16                9                8 
Lost to Follow-up                17                5                4 
Lack of Efficacy                0                1                1 
Met BP Or Pulse Withdrawal Criteria                4                2                0 
Not Specified                2                5                4 
[1] These subjects were not included in the Safety Analysis Set or Full Analysis Set.
[2] One subject was randomized to this arm but did not receive at least 1 dose of double-blind treatment



  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.

Reporting Groups
  Description
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 a 20, 30, 50, or 70 mg dose) for 8 weeks.
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) for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Antidepressant + Double-blind SPD489   Antidepressant + Double-blind Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 211   213   424 
Age 
[Units: Years]
Mean (Standard Deviation) 		 42  (11.63)   42.6  (11.41)   42.3  (11.51) 
Age, Customized 
[Units: Participants]
 		     
18-55 years   181   184   365 
56-65 years   30   29   59 
Gender 
[Units: Participants]
 		     
Female   141   143   284 
Male   70   70   140 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 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:   Percent 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: Up to 8 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores   [ 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 in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male   [ Time Frame: Up to 8 weeks ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female   [ Time Frame: Up to 8 weeks ]
  Show Outcome Measure 10

11.  Secondary:   Clinical Global Impressions - Global Improvement (CGI-I)   [ Time Frame: Up to 8 weeks ]
  Show Outcome Measure 11

12.  Secondary:   Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI)   [ Time Frame: Up to 8 weeks ]
  Show Outcome Measure 12

13.  Secondary:   Columbia Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Up to 8 weeks ]
  Show Outcome Measure 13

14.  Secondary:   Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score   [ Time Frame: 8 weeks ]
  Show Outcome Measure 14


  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 Development LLC
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01436162     History of Changes
Other Study ID Numbers: SPD489-323
2011-003006-25 ( EudraCT Number )
Study First Received: September 15, 2011
Results First Received: October 31, 2014
Last Updated: November 6, 2014