Clinical trial NCT00905424: Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 246
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 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD

Exclusion Criteria:

* History of non-response to multiple antidepressants

Primary outcomes:
measure: Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)
timeFrame: Augmentation Baseline, 6 weeks
Secondary outcomes:
measure: Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF
timeFrame: Augmentation Baseline, 6 weeks
measure: Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6
timeFrame: Augmentation Baseline, 6 weeks
measure: Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF
timeFrame: 6 weeks
measure: Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline
timeFrame: Augmentation baseline
measure: Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6
timeFrame: 6 weeks
measure: Change From Augmentation Baseline for Non-Remitters in the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Scale Total Score at Week 6
timeFrame: Augmentation Baseline and 6 weeks
measure: Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6
timeFrame: Augmentation Baseline and 6 weeks
measure: Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6
timeFrame: Augmentation Baseline and 6 weeks
measure: Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF
timeFrame: Augmentation Baseline and 6 weeks
measure: Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF
timeFrame: Augmentation Baseline and 6 weeks
measure: Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6
timeFrame: Augmentation Baseline and 6 weeks
measure: Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF
timeFrame: 6 weeks
measure: Assessment in Remitters of CGI-S at Augmentation Baseline
timeFrame: Augmentation Baseline
measure: Assessment in Remitters of CGI-S at Week 6
timeFrame: 6 weeks
measure: Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6
timeFrame: Augmentation baseline and 6 weeks
measure: Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6
timeFrame: Augmentation baseline and 6 weeks
measure: Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6
timeFrame: Augmentation baseline and 6 weeks
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (PRI)
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
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: Overland Park
country: United States
facility: Vince & Associates Clinical Research
state: Kansas
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle), LLC
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Trivedi MH, Cutler AJ, Richards C, Lasser R, Geibel BB, Gao J, Sambunaris A, Patkar AA. A randomized controlled trial of the efficacy and safety of lisdexamfetamine dimesylate as augmentation therapy in adults with residual symptoms of major depressive disorder after treatment with escitalopram. J Clin Psychiatry. 2013 Aug;74(8):802-9. doi: 10.4088/JCP.13m08360.