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SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00985725
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : April 6, 2012
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SPD489 (Lisdexamfetamine dimesylate) Drug: Matching placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
SPD489
Drug: SPD489 (Lisdexamfetamine dimesylate)
Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
Other Name: Vyvanse

Placebo Comparator: Placebo
Placebo
Drug: Matching placebo
oral, once daily




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. Percent of Participants With CGI-S at up to 9 Weeks/Endpoint [ Time Frame: Up to 9 weeks/Endpoint ]
    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)

  6. Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF [ Time Frame: Week 9 ]
    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.

  7. 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 ]
    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.

  8. 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.

  9. 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.

  10. 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).

  11. 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.

  12. Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11 [ Time Frame: Baseline and week 11 ]
    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.

  13. Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF [ Time Frame: Baseline and week 9 ]
    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.

  14. Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9 [ Time Frame: Baseline and week 9 ]
    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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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression

Exclusion Criteria:

  • Current co-morbid psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985725


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Locations
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United States, California
Sun Valley Research Center
Imperial, California, United States, 92251
Pharmacology Research Center
Los Alamitos, California, United States, 90720
Excell Research
Oceanside, California, United States, 92056
Neuropsychiatric Resesarch Center of Orange County
Santa Ana, California, United States, 92701
United States, Connecticut
Connecticut Clincal Research
Cromwell, Connecticut, United States, 06416
United States, Florida
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32216
Amit Vijapura, MD
Jacksonville, Florida, United States, 32256
Scientific Clinical Research, Inc.
North Miami, Florida, United States, 33161
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Institute of Medicine & Research
Atlanta, Georgia, United States, 30328
Carman Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Joliet Center for Clinical Research
Joliet, Illinois, United States, 60435
Capstone Clinical Research
Libertyville, Illinois, United States, 60048
United States, Kansas
Psychiatric Associates
Overland Park, Kansas, United States, 66211
United States, Massachusetts
AccelRx Research
Fall River, Massachusetts, United States, 02721
United States, Missouri
St. Charles Psychiatric Associates
St. Charles, Missouri, United States, 63301
PsychCare Consultants Research
St. Louis, Missouri, United States, 63128
United States, Nebraska
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States, 68510
United States, New York
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
United States, North Carolina
North Carolina Neuropsychiatry, PA
Chapel Hill, North Carolina, United States, 27514
Duke University Medical Center
Durham, North Carolina, United States, 27705
Richard H. Weisler, MD, PA & Associates
Raleigh, North Carolina, United States, 27609
United States, Ohio
Patient Priority Clinical Sites, LLC
Cincinnatti, Ohio, United States, 45242
United States, Pennsylvania
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
Paramount Clinical Research
Bridgeville, Pennsylvania, United States, 15017
Suburban Research Associates
Media, Pennsylvania, United States, 19063
United States, Texas
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States, 75231
Bayou City Resesarch, LTD
Houston, Texas, United States, 77007
Red Oak Psychiatry Associates, PA
Houston, Texas, United States, 77090
University Hills Clinical Research
Irving, Texas, United States, 75062
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Wharton Research Center
Wharton, Texas, United States, 77488
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Shire
Investigators
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Principal Investigator: Richard Keefe, PhD Duke University Medical Center, Durham, NC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00985725     History of Changes
Other Study ID Numbers: SPD489-205
First Posted: September 28, 2009    Key Record Dates
Results First Posted: April 6, 2012
Last Update Posted: March 23, 2015
Last Verified: March 2012
Keywords provided by Shire:
Major Depressive Disorder
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents