Phase 2 N=177 Randomized Triple-blind Treatment

Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

Major Depressive Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00905424 ↗

Enrolled (actual)

177

Serious AEs

0.6%

Results posted

Jul 2011

Primary outcome: Primary: Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF) — -7.1; -4.9 Units on a scale — p=0.0902

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Antidepressant + SPD489 (lisdexamfetamine dimesylate) (Drug); Antidepressant + placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Augmentation Baseline for Non-Remitters in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 6 - Last Observation Carried Forward (LOCF)	-7.1; -4.9	0.0902
SECONDARY Change From Augmentation Baseline for Non-Remitters in the Hamilton Depression Scale (HAM-D) Total Score at Week 6 - LOCF	-4.9; -4.0	0.3091
SECONDARY Change From Augmentation Baseline for Non-Remitters in the Sheehan Disability Scale (SDS) Total Score at Week 6	-3.7; -1.7	0.0573
SECONDARY Percentage of Non-Remitters With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 6 - LOCF	60.0; 45.3	0.2368
SECONDARY Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Augmentation Baseline	1.5; 1.6; 20.0; 12.5; 40.0; 34.4	—
SECONDARY Assessment in Non-Remitters of Clinical Global Impression-Severity of Illness (CGI-S) at Week 6	27.0; 14.5; 31.7; 24.2; 30.2; 22.6	—
SECONDARY 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	-4.7; -1.7; -3.7; -1.7; -4.8; -1.5	0.0463 sig
SECONDARY Change From Augmentation Baseline for Non-Remitters in the Multidimensional Assessment of Fatigue (MAF) Scale Total Score at Week 6	-5.3; -2.3	0.0920
SECONDARY Change From Augmentation Baseline for Non-Remitters in the Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) Scale Total Score at Week 6	-2.4; -1.2	0.0774
SECONDARY Change From Augmentation Baseline for Remitters in MADRS Total Score at Week 6 - LOCF	0.1; -1.1	0.4726
SECONDARY Change From Augmentation Baseline for Remitters in the HAM-D Total Score at Week 6 - LOCF	-0.8; -1.6	0.5182
SECONDARY Change From Augmentation Baseline for Remitters in the SDS Total Score at Week 6	-1.6; -0.6	0.4630
SECONDARY Percentage of Remitters With Improvement on CGI-I at Week 6 - LOCF	65.2; 52.4	0.5230
SECONDARY Assessment in Remitters of CGI-S at Augmentation Baseline	26.1; 23.8; 47.8; 71.4; 21.7; 4.8	—
SECONDARY Assessment in Remitters of CGI-S at Week 6	50.0; 61.9; 36.4; 23.8; 13.6; 9.5	—
SECONDARY Change From Augmentation Baseline for Remitters in the BRIEF-A Scale Total Score at Week 6	-0.9; -2.7; -0.4; -1.5; -1.1; -3.4	0.2876
SECONDARY Change From Augmentation Baseline for Remitters in the MAF Scale Total Score at Week 6	-4.0; -0.2	0.1489
SECONDARY Change From Augmentation Baseline for Remitters in the QIDS-SR Scale Total Score at Week 6	-1.9; -0.4	0.0852

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00905424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.