Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Antidepressant + placebo
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD
Exclusion Criteria:
- History of non-response to multiple antidepressants
Sites / Locations
- Pharmacology Research Institute (PRI)
- Affiliated Research Institute
- Florida Clinical Research Center, LLC
- Gulfcoast Clinical Research Center
- Clinical Neuroscience Solutions, Inc.
- Atlanta Institute of Medicine & Research
- Carman Research
- Vince & Associates Clinical Research
- Duke University Medical Center
- North Star Medical Research, LLC
- IPS Research Company
- Summit Research Network
- FutureSearch Clinical Trials, LP
- Northwest Clinical Research Center
- Summit Research Network (Seattle), LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Antidepressant + SPD489
Antidepressant + placebo
Outcomes
Primary Outcome Measures
Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Secondary Outcome Measures
Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6
BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.
Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Assessment in Remitters of CGI-S at Augmentation Baseline
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Assessment in Remitters of CGI-S at Week 6
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6
BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00905424
Brief Title
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 30, 2009 (Actual)
Primary Completion Date
August 4, 2010 (Actual)
Study Completion Date
August 4, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Antidepressant + SPD489
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Antidepressant + placebo
Intervention Type
Drug
Intervention Name(s)
Antidepressant + SPD489 (lisdexamfetamine dimesylate)
Other Intervention Name(s)
LDX, Vyvanse
Intervention Description
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Antidepressant + placebo
Intervention Description
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks
Primary Outcome Measure Information:
Title
Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)
Description
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame
Augmentation Baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF
Description
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Time Frame
Augmentation Baseline, 6 weeks
Title
Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6
Description
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Time Frame
Augmentation Baseline, 6 weeks
Title
Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF
Description
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame
6 weeks
Title
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline
Description
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame
Augmentation baseline
Title
Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6
Description
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame
6 weeks
Title
Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6
Description
BRIEF-A is a validated 75-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to develop interpretive reports. Lower scores reflect better functioning.
Time Frame
Augmentation Baseline and 6 weeks
Title
Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6
Description
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Time Frame
Augmentation Baseline and 6 weeks
Title
Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6
Description
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Time Frame
Augmentation Baseline and 6 weeks
Title
Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF
Description
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame
Augmentation Baseline and 6 weeks
Title
Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF
Description
The HAM-D is a validated rating scale which consists of 17 items. Nine of the items are scored on a scale of 0-4 and 8 items are scored on a scale of 0-2 for a total scoring range of 0-52. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates increased severity of depression. In general, the lower the total score the less severe the depression.
Time Frame
Augmentation Baseline and 6 weeks
Title
Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6
Description
Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.
Time Frame
Augmentation Baseline and 6 weeks
Title
Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF
Description
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame
6 weeks
Title
Assessment in Remitters of CGI-S at Augmentation Baseline
Description
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame
Augmentation Baseline
Title
Assessment in Remitters of CGI-S at Week 6
Description
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame
6 weeks
Title
Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6
Description
BRIEF-A is a validated 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
Time Frame
Augmentation baseline and 6 weeks
Title
Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6
Description
MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.
Time Frame
Augmentation baseline and 6 weeks
Title
Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6
Description
QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression.
Time Frame
Augmentation baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD
Exclusion Criteria:
History of non-response to multiple antidepressants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Pharmacology Research Institute (PRI)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Atlanta Institute of Medicine & Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Vince & Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
FutureSearch Clinical Trials, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Summit Research Network (Seattle), LLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24021497
Citation
Trivedi MH, Cutler AJ, Richards C, Lasser R, Geibel BB, Gao J, Sambunaris A, Patkar AA. A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. J Clin Psychiatry. 2013 Aug;74(8):802-9. doi: 10.4088/JCP.13m08360.
Results Reference
result
Links:
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA Recall Information
URL
http://www.vyvanse.com/pdf/prescribing_information.pdf
Description
FDA-approved Labelling
Learn more about this trial
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
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