Clinical trial NCT00985725: SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Current co-morbid psychiatric disorder

Primary outcomes:
measure: 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)
timeFrame: Baseline and week 9
Secondary outcomes:
measure: Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF)
timeFrame: Baseline and week 9
measure: Change From Baseline in BRIEF-A T-scores at Week 9, LOCF
timeFrame: Baseline and week 9
measure: Change From Baseline in Central Nervous System Vital Signs Computerized Cognitive Testing Battery Neurocognitive Domain and Index Scores at up to 9 Weeks/Endpoint
timeFrame: Baseline and up to 9 weeks/Endpoint
measure: Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
timeFrame: Baseline
measure: Percent of Participants With CGI-S at up to 9 Weeks/Endpoint
timeFrame: Up to 9 weeks/Endpoint
measure: Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF
timeFrame: Week 9
measure: Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint
timeFrame: Baseline and up to 9 weeks/Endpoint
measure: Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF
timeFrame: Baseline and week 9
measure: Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF
timeFrame: Baseline and week 9
measure: Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9
timeFrame: Baseline and week 9
measure: Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint
timeFrame: Baseline and up to 9 weeks/Endpoint
measure: Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11
timeFrame: Baseline and week 11
measure: Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF
timeFrame: Baseline and week 9
measure: Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9
timeFrame: Baseline and week 9
Other outcomes:
Locations:
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Resesarch Center of Orange County
state: California
city: Cromwell
country: United States
facility: Connecticut Clincal Research
state: Connecticut
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Amit Vijapura, MD
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine & Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Joliet
country: United States
facility: Joliet Center for Clinical Research
state: Illinois
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Fall River
country: United States
facility: AccelRx Research
state: Massachusetts
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Chapel Hill
country: United States
facility: North Carolina Neuropsychiatry, PA
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Richard H. Weisler, MD, PA & Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP
state: Texas
city: Houston
country: United States
facility: Bayou City Resesarch, LTD
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Wharton
country: United States
facility: Wharton Research Center
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Madhoo M, Keefe RS, Roth RM, Sambunaris A, Wu J, Trivedi MH, Anderson CS, Lasser R. Lisdexamfetamine dimesylate augmentation in adults with persistent executive dysfunction after partial or full remission of major depressive disorder. Neuropsychopharmacology. 2014 May;39(6):1388-98. doi: 10.1038/npp.2013.334. Epub 2013 Dec 6.