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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01436175




Registration number
NCT01436175
Ethics application status
Date submitted
15/09/2011
Date registered
19/09/2011
Date last updated
14/06/2021

Titles & IDs
Public title
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
Scientific title
A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant
Secondary ID [1] 0 0
2011-003019-47
Secondary ID [2] 0 0
SPD489-329
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

Experimental: SPD489 + Antidepressant -


Treatment: Drugs: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [1] 0 0
Week 5 up to Week 52/Early Termination(ET)
Primary outcome [2] 0 0
Change From Baseline in Systolic Blood Pressure at Week 52
Timepoint [2] 0 0
Baseline, Week 52/ET
Primary outcome [3] 0 0
Change From Baseline in Diastolic Blood Pressure at Week 52
Timepoint [3] 0 0
Baseline, Week 52/ET
Primary outcome [4] 0 0
Change From Baseline in Pulse Rate at Week 52
Timepoint [4] 0 0
Baseline, Week 52/ET
Secondary outcome [1] 0 0
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
Timepoint [1] 0 0
Baseline, Week 52/ET
Secondary outcome [2] 0 0
Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
Timepoint [2] 0 0
Week 52/ET
Secondary outcome [3] 0 0
Short Form-12 Health Survey Version 2 (SF-12V2)
Timepoint [3] 0 0
Week 52/ET
Secondary outcome [4] 0 0
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
Timepoint [4] 0 0
Week 52/ET
Secondary outcome [5] 0 0
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
Timepoint [5] 0 0
Week 52/ET
Secondary outcome [6] 0 0
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
Timepoint [6] 0 0
Week 52/ET
Secondary outcome [7] 0 0
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
Timepoint [7] 0 0
Week 52/ET
Secondary outcome [8] 0 0
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
Timepoint [8] 0 0
Week 52/ET
Secondary outcome [9] 0 0
EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale
Timepoint [9] 0 0
Week 52/ET
Secondary outcome [10] 0 0
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Timepoint [10] 0 0
Week 52/ET
Secondary outcome [11] 0 0
Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Timepoint [11] 0 0
Week 52/ET
Secondary outcome [12] 0 0
Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
Timepoint [12] 0 0
Baseline, Week 52/ET
Secondary outcome [13] 0 0
Amphetamine Cessation Symptom Assessment (ACSA) Total Score
Timepoint [13] 0 0
Week 53
Secondary outcome [14] 0 0
Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
Timepoint [14] 0 0
Week 52/ET
Secondary outcome [15] 0 0
PRUQ-MDD - Number of Days of Resource Utilization
Timepoint [15] 0 0
Week 52/ET
Secondary outcome [16] 0 0
PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
Timepoint [16] 0 0
Week 52/ET
Secondary outcome [17] 0 0
PRUQ-MDD - Number of Hours
Timepoint [17] 0 0
Week 52/ET
Secondary outcome [18] 0 0
PRUQ-MDD - Effect of Depressive Symptoms
Timepoint [18] 0 0
Week 52/ET

Eligibility
Key inclusion criteria
* Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/03/2014
Sample size
Target
Accrual to date
Final
1570
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Canada
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Canada
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Litomerice
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Prague
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Tartu
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Kuopio
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Finland
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Turku
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Leipzig
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Germany
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Munchen
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Germany
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Nuernberg
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Germany
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Schwerin
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Germany
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Westerstede
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Germany
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Wuerzburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Mexico
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Mazatian
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Mexico
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Monterrey
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Poland
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Bialystok
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Chelmno
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Gdansk
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Gorlice
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Kielce
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Zuromin
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Targoviste
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Romania
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Targu Mures
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South Africa
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Cape Town
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Oviedo
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Spain
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Salamanca
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Spain
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Zamora
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Spain
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Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.
Trial website
https://clinicaltrials.gov/study/NCT01436175
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01436175