SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study enrolled eligible adults with major depressive disorder (MDD) who had completed treatment in a short-term antecedent SPD489 (lisdexamfetamine dimesylate) MDD study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).

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
SPD489 + Antidepressant	SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.

Participant Flow:   Overall Study

	SPD489 + Antidepressant
STARTED	1570
COMPLETED	300
NOT COMPLETED	1270
Adverse Event	111
Protocol Violation	49
Withdrawal by Subject	108
Lost to Follow-up	89
Lack of Efficacy	24
Met blood pressure or pulse withdrawal	63
Unspecified	826

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 included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study.

Reporting Groups

	Description
SPD489 + Antidepressant	SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.

Baseline Measures

	SPD489 + Antidepressant
Overall Participants Analyzed  [Units: Participants]	1559
Age  [Units: Years] Mean (Standard Deviation)	41.9  (11.89)
Age, Customized  [Units: Participants]
18-55 Years	1333
56-65 Years	226
Gender  [Units: Participants]
Female	1056
Male	503
Region of Enrollment  [Units: Participants]
United States	1190
Estonia	24
Hungary	4
Czech Republic	83
Mexico	27
Canada	36
Finland	8
Spain	6
Poland	20
Romania	8
South Africa	5
Chile	33
Germany	69
Argentina	27
Australia	13
United Kingdom	1
Croatia	5

1.  Primary:

Columbia-Suicide Severity Rating Scale (C-SSRS)   [ Time Frame: Week 5 up to Week 52/Early Termination(ET) ]

2.  Primary:

Change From Baseline in Systolic Blood Pressure at Week 52   [ Time Frame: Baseline, Week 52/ET ]

3.  Primary:

Change From Baseline in Diastolic Blood Pressure at Week 52   [ Time Frame: Baseline, Week 52/ET ]

4.  Primary:

Change From Baseline in Pulse Rate at Week 52   [ Time Frame: Baseline, Week 52/ET ]

5.  Secondary:

Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET   [ Time Frame: Baseline, Week 52/ET ]

6.  Secondary:

Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)   [ Time Frame: Week 52/ET ]

7.  Secondary:

Short Form-12 Health Survey Version 2 (SF-12V2)   [ Time Frame: Week 52/ET ]

8.  Secondary:

EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility   [ Time Frame: Week 52/ET ]

9.  Secondary:

EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care   [ Time Frame: Week 52/ET ]

10.  Secondary:

EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities   [ Time Frame: Week 52/ET ]

11.  Secondary:

EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort   [ Time Frame: Week 52/ET ]

12.  Secondary:

EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression   [ Time Frame: Week 52/ET ]

13.  Secondary:

EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale   [ Time Frame: Week 52/ET ]

14.  Secondary:

Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)   [ Time Frame: Week 52/ET ]

15.  Secondary:

Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)   [ Time Frame: Week 52/ET ]

16.  Secondary:

Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET   [ Time Frame: Baseline, Week 52/ET ]

17.  Secondary:

Amphetamine Cessation Symptom Assessment (ACSA) Total Score   [ Time Frame: Week 53 ]

18.  Secondary:

Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)   [ Time Frame: Week 52/ET ]

19.  Secondary:

PRUQ-MDD – Number of Days of Resource Utilization   [ Time Frame: Week 52/ET ]

20.  Secondary:

PRUQ-MDD – Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)   [ Time Frame: Week 52/ET ]

21.  Secondary:

PRUQ-MDD – Number of Hours   [ Time Frame: Week 52/ET ]

22.  Secondary:

PRUQ-MDD – Effect of Depressive Symptoms   [ Time Frame: Week 52/ET ]

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
The study was terminated on 11 Feb 2014. SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants. Termination was not related to any new safety findings.