Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01436149 | Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder | PHASE3 | COMPLETED | 1,262 | — | — | Oct 27, 2011 | Dec 23, 2013 | Jun 9, 2021 | 85 | United States, Canada +4 |
| NCT00985725 | SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder | PHASE2 | COMPLETED | 143 | — | — | Oct 29, 2009 | Apr 18, 2011 | Jun 8, 2021 | 33 | United States |
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
| Arm | Type | Description |
|---|---|---|
| Antidepressant + SPD489 | EXPERIMENTAL | - |
| Antidepressant + Placebo | PLACEBO_COMPARATOR | - |
| Active | EXPERIMENTAL | SPD489 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| SPD489 (Lisdexamfetamine dimesylate ) | DRUG | Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks |
| Placebo | DRUG | Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks |
| SPD489 (Lisdexamfetamine dimesylate) | DRUG | Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily |
| Matching placebo | DRUG | oral, once daily |
Inclusion Criteria: * Subject is able to provide written, personally signed, and dated informed consent to participate in the study. * Subject is between 18 and 65 years of age. * Subject has a primary diagnosis of non-psychotic MDD (single or recurrent). * Subject has a MADRS total score 24. * Sub...