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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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Antidepressant + SPD489 is an investigational combination treatment being studied for major depressive disorder, in which SPD489 (lisdexamfetamine dimesylate) is added to an existing antidepressant as augmentation therapy. It is a small molecule developed by Takeda Pharmaceutical Company Limited (ticker TAK) and has been evaluated in Phase 3 clinical development.
Antidepressant + SPD489 is being studied as augmentation therapy for adults with major depressive disorder, meaning SPD489 is added to an antidepressant rather than used alone. The trials enrolled adults 18 years and older with MDD. It is investigational and is not an approved treatment for major depressive disorder.
Antidepressant + SPD489 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the clinical trials evaluating SPD489 as augmentation therapy added to an antidepressant in adults with major depressive disorder.
Antidepressant + SPD489 has been studied in Phase 3 clinical development for major depressive disorder. Three trials have been completed, including one Phase 3 study and two Phase 2 studies, and no trials are currently active. The program is investigational and has not been approved for marketing.
Three completed trials have evaluated Antidepressant + SPD489 in major depressive disorder: NCT01436162, a Phase 3 study of SPD489 combined with an antidepressant; NCT01435759, a Phase 2 study of the same combination; and NCT00905424, an exploratory Phase 2 study of SPD489 as augmentation therapy. Together they enrolled 2,548 participants.
Yes. SPD489 is the development code for lisdexamfetamine dimesylate, so Antidepressant + SPD489 refers to lisdexamfetamine dimesylate given together with an antidepressant. The combination is studied as augmentation therapy in major depressive disorder, while lisdexamfetamine dimesylate itself is a small molecule developed by Takeda.