Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Antidepressant+ SPD489 · 3 trials · 1 indication
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.
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. CHange in MADRS total score in Augmentsion Baseline to Week 16.
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.
| Arm | Type | Description |
|---|---|---|
| Antidepressant + SPD489 | EXPERIMENTAL | - |
| Antidepressant + Placebo | PLACEBO_COMPARATOR | - |
| Antidepressant + SPD489 10 mg | EXPERIMENTAL | - |
| Antidepressant + SPD489 30 mg | EXPERIMENTAL | - |
| Antidepressant + SPD489 50 mg | EXPERIMENTAL | - |
| Antidepressant + SPD489 70 mg | EXPERIMENTAL | - |
| Active | EXPERIMENTAL | Antidepressant + SPD489 |
| Placebo | PLACEBO_COMPARATOR | Antidepressant + placebo |
| Name | Type | Description |
|---|---|---|
| Antidepressant + 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 |
| Antidepressant + 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 |
| Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg | DRUG | Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks |
| Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg | DRUG | Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks |
| Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg | DRUG | Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks |
| Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg | DRUG | Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks |
| Antidepressant + SPD489 (lisdexamfetamine dimesylate) | DRUG | Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks |
Inclusion Criteria 1. Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. 2. Subject is between 18 and 65 years of age. 3. Subject has a primary diagnosis of non-psychotic MDD. 4. Subject has a...
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