- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00985725
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
May 16, 2021 updated by: Shire
Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
To evaluate the efficacy of SPD489 for the treatment of executive function impairments (EFI) when used as an adjunct to stable, standard therapy in the setting of partial or full remission from recurrent Major Depressive Disorder (MDD) as measured by the Global Executive Composite (GEC) T-score of the Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Imperial, California, United States, 92251
- Sun Valley Research Center
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Los Alamitos, California, United States, 90720
- Pharmacology Research Center
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Oceanside, California, United States, 92056
- Excell Research
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Santa Ana, California, United States, 92701
- Neuropsychiatric Resesarch Center of Orange County
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Connecticut
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Cromwell, Connecticut, United States, 06416
- Connecticut Clincal Research
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Florida
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Jacksonville, Florida, United States, 32216
- Clinical Neuroscience Solutions, Inc.
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Jacksonville, Florida, United States, 32256
- Amit Vijapura, MD
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North Miami, Florida, United States, 33161
- Scientific Clinical Research, Inc.
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Orlando, Florida, United States, 32806
- Clinical Neuroscience Solutions, Inc.
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Georgia
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Atlanta, Georgia, United States, 30328
- Atlanta Institute of Medicine & Research
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Smyrna, Georgia, United States, 30080
- Carman Research
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Illinois
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Joliet, Illinois, United States, 60435
- Joliet Center for Clinical Research
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Libertyville, Illinois, United States, 60048
- Capstone Clinical Research
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Kansas
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Overland Park, Kansas, United States, 66211
- Psychiatric Associates
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Massachusetts
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Fall River, Massachusetts, United States, 02721
- AccelRx Research
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Missouri
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Saint Charles, Missouri, United States, 63301
- St. Charles Psychiatric Associates
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Saint Louis, Missouri, United States, 63128
- PsychCare Consultants Research
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Premier Psychiatric Research Institute, LLC
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New York
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Staten Island, New York, United States, 10312
- Richmond Behavioral Associates
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- North Carolina Neuropsychiatry, PA
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Durham, North Carolina, United States, 27705
- Duke University Medical Center
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Raleigh, North Carolina, United States, 27609
- Richard H. Weisler, MD, PA & Associates
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Ohio
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Cincinnati, Ohio, United States, 45242
- Patient Priority Clinical Sites, LLC
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Lehigh Center for Clinical Research
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Bridgeville, Pennsylvania, United States, 15017
- Paramount Clinical Research
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Media, Pennsylvania, United States, 19063
- Suburban Research Associates
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Texas
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Dallas, Texas, United States, 75231
- FutureSearch Trials of Dallas, LP
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Houston, Texas, United States, 77090
- Red Oak Psychiatry Associates, PA
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Houston, Texas, United States, 77007
- Bayou City Resesarch, LTD
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Irving, Texas, United States, 75062
- University Hills Clinical Research
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Lake Jackson, Texas, United States, 77566
- R/D Clinical Research, Inc.
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Wharton, Texas, United States, 77488
- Wharton Research Center
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Washington
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Bellevue, Washington, United States, 98007
- Northwest Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression
Exclusion Criteria:
- Current co-morbid psychiatric disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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oral, once daily
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Experimental: Active
SPD489
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Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)
Time Frame: Baseline and week 9
|
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function.
Items are rated 1 (never), 2 (sometimes), and 3 (often).
There is no range for a total score.
Raw scale scores are used to generate T-scores.
A reduction in score indicates less impairment.
|
Baseline and week 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
Time Frame: 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)
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Baseline
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Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)
Time Frame: Baseline and week 9
|
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.
|
Baseline and week 9
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Change From Baseline in BRIEF-A T-scores at Week 9, LOCF
Time Frame: Baseline and week 9
|
BRIEF-A is a validated 75-item questionnaire.
Items are rated 1 (never), 2 (sometimes), and 3 (often).
There is no range for a total score.
Raw scale scores are used to generate T-scores.
A reduction in score indicates less impairment.
|
Baseline and week 9
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Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint
Time Frame: Baseline and up to 9 weeks/Endpoint
|
This measures the speed and accuracy of basic mental functions.
Scores are normalized from raw scores and present an age matched score relative to other people in a normative sample.
Scores are normalized with a mean of 100 and standard deviation of 15.
Scores < 70 indicate likely deficit and impairment, and scores > 110 indicate high function and capacity.
Higher scores are better.
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Baseline and up to 9 weeks/Endpoint
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Percent of Participants With CGI-S at up to 9 Weeks/Endpoint
Time Frame: Up to 9 weeks/Endpoint
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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)
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Up to 9 weeks/Endpoint
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Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF
Time Frame: Week 9
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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.
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Week 9
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Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint
Time Frame: Baseline and up to 9 weeks/Endpoint
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The EWPS quantifies work performance, productivity attitudes and behaviors assessing 25 items on a scale ranging from 0 (high performance) to 4 (lowest performance).
Scores range from 0 to 100 with 100 representing lowest productivity.
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Baseline and up to 9 weeks/Endpoint
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Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF
Time Frame: Baseline and week 9
|
This is a 14 item self-report tool that evaluates sexual functioning.
Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70.
Higher scores reflect better sexual functioning.
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Baseline and week 9
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Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF
Time Frame: Baseline and week 9
|
This is a 14 item self-report tool that evaluates sexual functioning.
Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70.
Higher scores reflect better sexual functioning.
|
Baseline and week 9
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Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9
Time Frame: Baseline and week 9
|
The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey.
The survey captures physical and mental health.
Each of the 12 items is scored using various scales with a total score ranging from 0 (lowest level of health) to 100 (highest level of health).
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Baseline and week 9
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Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint
Time Frame: Baseline and up to 9 weeks/Endpoint
|
The Q-LES-Q is a 93-item self-report questionnaire on quality of life and health.
Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good) with a total score ranging from 93 to 465.
Higher scores indicate greater satisfaction.
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Baseline and up to 9 weeks/Endpoint
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Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11
Time Frame: Baseline and week 11
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ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64.
Higher scores indicate greater withdrawal symptom severity.
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Baseline and week 11
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Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF
Time Frame: Baseline and week 9
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The GAD-7 is a 7-item self-report questionnaire for assessing anxiety severity.
Each item is scored using a scale that ranges from 0 (not at all) to 3 (nearly every day) with total scores ranging from 0 to 21. Lower scores indicate a reduction in anxiety.
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Baseline and week 9
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Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9
Time Frame: Baseline and week 9
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The STS is an 8-question clinician-rated assessment of suicidal ideation, suicidal behavior, and accidents.
The items are scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely) and summed to produce a total score ranging from 0 to 32.
Lower scores indicate reduced suicidal tendencies.
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Baseline and week 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2009
Primary Completion (Actual)
April 18, 2011
Study Completion (Actual)
April 18, 2011
Study Registration Dates
First Submitted
September 25, 2009
First Submitted That Met QC Criteria
September 25, 2009
First Posted (Estimate)
September 28, 2009
Study Record Updates
Last Update Posted (Actual)
June 8, 2021
Last Update Submitted That Met QC Criteria
May 16, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Lisdexamfetamine Dimesylate
Other Study ID Numbers
- SPD489-205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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