Phase 2
Completed N=177
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
Source: ClinicalTrials.gov NCT00905424 ↗Enrolled (actual)
177
Serious AEs
0.6%
Results posted
Jul 2011
Primary outcomePrimary: 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
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.
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 |
Eligibility Criteria
Inclusion Criteria
- Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD
Exclusion Criteria
- History of non-response to multiple antidepressants
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. Informational only — not medical advice.