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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985725
• Other study ID #: SPD489-205
• Status: Completed
• Phase: Phase 2
• Start date: October 29, 2009
• Est. completion date: April 18, 2011

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: April 18, 2011
• Est. primary completion date: April 18, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Current co-morbid psychiatric disorder

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• SPD489 (Lisdexamfetamine dimesylate)
Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily
• Matching placebo
oral, once daily

Locations

Country	Name	City	State
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Atlanta Institute of Medicine & Research	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Paramount Clinical Research	Bridgeville	Pennsylvania
United States	North Carolina Neuropsychiatry, PA	Chapel Hill	North Carolina
United States	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio
United States	Connecticut Clincal Research	Cromwell	Connecticut
United States	FutureSearch Trials of Dallas, LP	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	AccelRx Research	Fall River	Massachusetts
United States	Bayou City Resesarch, LTD	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Sun Valley Research Center	Imperial	California
United States	University Hills Clinical Research	Irving	Texas
United States	Amit Vijapura, MD	Jacksonville	Florida
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Joliet Center for Clinical Research	Joliet	Illinois
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Premier Psychiatric Research Institute, LLC	Lincoln	Nebraska
United States	Pharmacology Research Center	Los Alamitos	California
United States	Suburban Research Associates	Media	Pennsylvania
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	Excell Research	Oceanside	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Richard H. Weisler, MD, PA & Associates	Raleigh	North Carolina
United States	St. Charles Psychiatric Associates	Saint Charles	Missouri
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	Neuropsychiatric Resesarch Center of Orange County	Santa Ana	California
United States	Carman Research	Smyrna	Georgia
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Wharton Research Center	Wharton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

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