drugset / Trial / NCT00985725
SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2009-10-29
- Primary completion
- 2011-04-18
- Completion
- 2011-04-18
Outcome
Met primary endpoint
paper the LS mean (95% CI) treatment difference significantly favored LDX (-8.0 (-12.7, -3.3); P=0.0009). PMID 24309905 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 20 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 30 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 40 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 50 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 60 mg | Oral |
| Subject | Lisdexamfetamine Dimesylate | Small molecule | 70 mg | Oral |