Phase 2
N=143
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00985725 ↗Enrolled (actual)
143
Serious AEs
4.2%
Results posted
Apr 2012
Primary outcome: 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) — -21.2; -13.2 T-scores — p=0.0009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPD489 (Lisdexamfetamine dimesylate) (Drug); Matching placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
-21.2; -13.2 | 0.0009 sig |
| SECONDARY Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score at Week 9 - (LOCF) |
-5.0; -3.1 | 0.0465 sig |
| SECONDARY Change From Baseline in BRIEF-A T-scores at Week 9, LOCF |
-17.4; -12.3; -13.5; -9.3; -16.2; -10.6 | 0.0181 sig |
| 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 |
8.7; 3.7; 11.0; 6.0; 11.5; 2.5 | — |
| SECONDARY Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline |
0.0; 2.8; 7.0; 8.3; 42.3; 36.1 | — |
| SECONDARY Percent of Participants With CGI-S at up to 9 Weeks/Endpoint |
21.7; 15.9; 40.6; 23.2; 20.3; 24.6 | — |
| SECONDARY Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Week 9, LOCF |
60.6; 38.9 | — |
| SECONDARY Change From Baseline in Endicott Work Productivity Scale (EWPS) Total Score at up to 9 Weeks/Endpoint |
-20.4; -15.9 | 0.1731 |
| SECONDARY Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Scores for Males at Week 9, LOCF |
2.5; 2.4 | — |
| SECONDARY Change From Baseline in CSFQ-14 Total Scores for Females at Week 9, LOCF |
2.7; 1.6 | — |
| SECONDARY Change From Baseline in Short Form-12 Health Survey (SF-12) Scale Total Scores at Week 9 |
-0.10; -0.23; 0.69; 0.63 | — |
| SECONDARY Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Scores at up to 9 Weeks/Endpoint |
17.9; 8.2; 12.1; 9.1 | — |
| SECONDARY Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 11 |
-9.4; -5.9 | — |
| SECONDARY Change From Baseline in the Generalized Anxiety Disorder 7-Item (GAD-7) Total Score at Week 9, LOCF |
-4.4; -3.8 | — |
| SECONDARY Change From Baseline in Sheehan Suicidality Tracking Scale (STS) Total Score at Week 9 |
-0.1; 0.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00985725). 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.