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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: SPD489 (Lisdexamfetamine dimesylate); Drug: Matching placebo

• Registration Number: NCT00985725
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Study Start: 2009-10-29
• Primary Completion: 2011-04-18
• Study Completion: 2011-04-18
• Results First Submitted: 2012-02-07
• Results First Submitted QC: 2012-03-09
• Results First Posted: 2012-04-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-16
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

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

Exclusion Criteria

• Current co-morbid psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	SPD489 (Lisdexamfetamine dimesylate)	SPD489
Placebo	Matching placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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)	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

Name	Time	Method
Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)	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.
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF	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.
Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint	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.
Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF	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.
Change From Baseline in BRIEF-A T-scores at Week 9, LOCF	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.
Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint	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.
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline	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)
Percent of Participants With CGI-S at up to 9 Weeks/Endpoint	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)
Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF	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.
Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9	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).
Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint	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.
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11	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.
Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF	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.
Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9	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.

Trial Locations

Locations (32)

Sun Valley Research Center; 🇺🇸 Imperial, California, United States

Pharmacology Research Center; 🇺🇸 Los Alamitos, California, United States

Excell Research; 🇺🇸 Oceanside, California, United States

Neuropsychiatric Resesarch Center of Orange County; 🇺🇸 Santa Ana, California, United States

Connecticut Clincal Research; 🇺🇸 Cromwell, Connecticut, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Orlando, Florida, United States

Amit Vijapura, MD; 🇺🇸 Jacksonville, Florida, United States

Scientific Clinical Research, Inc.; 🇺🇸 North Miami, Florida, United States

Atlanta Institute of Medicine & Research; 🇺🇸 Atlanta, Georgia, United States

Carman Research; 🇺🇸 Smyrna, Georgia, United States

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