At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 246 enrolled
Drug / intervention
Antidepressant + SPD489 (lisdexamfetamine dimesylate) +1 moredrug
Likely dose
Antidepressant + SPD489 (lisdexamfetamine dimesylate) 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Exploratory Efficacy and Safety Study of SPD489 in Adults 18-55 Years With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant
In Brief
A Phase 2 clinical trial evaluating Antidepressant + SPD489 (lisdexamfetamine dimesylate) and Antidepressant + placebo for Major Depressive Disorder. Completed, enrolled 246 participants across 15 sites.
Detailed Summary
To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartJul 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedMay 20, 2009
Enrollment StartJul 30, 2009
Primary CompletionAug 4, 2010
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 17.1 years ago
Interventions
Antidepressant + SPD489 (lisdexamfetamine dimesylate)drug
Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks
Antidepressant + placebodrug
Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks