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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00985725
First received: September 25, 2009
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Matching placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF) [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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 Baseline in BRIEF-A T-scores at Week 9, LOCF [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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)

  • Percent of Participants With CGI-S at up to 9 Weeks/Endpoint [ Time Frame: Up to 9 weeks/Endpoint ] [ Designated as safety issue: No ]
    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)

  • Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: Yes ]
    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.

  • Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11 [ Time Frame: Baseline and week 11 ] [ Designated as safety issue: Yes ]
    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.

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

  • Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9 [ Time Frame: Baseline and week 9 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 143
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985725

  Show 33 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Richard Keefe, PhD Duke University Medical Center, Durham, NC
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00985725     History of Changes
Other Study ID Numbers: SPD489-205
Study First Received: September 25, 2009
Results First Received: February 7, 2012
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Recurrence
Mood Disorders
Mental Disorders
Behavioral Symptoms
Disease Attributes
Pathologic Processes
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014