CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 143 enrolled
Drug / intervention
SPD489 (Lisdexamfetamine dimesylate) +1 moredrug
Likely dose
SPD489 20–70 mg orally once dailyAI-extracted
Key inclusion· 2
  • ✓Age 18–55 years
  • ✓Primary diagnosis of nonpsychotic unipolar depression
Key exclusion· 1
  • ✕Current comorbid psychiatric disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00985725
NCT00985725Phase 2Completed
CompareCT.gov

Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults With Clinically Significant, Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

Shire·interventional·Posted Sep 28, 2009·Updated Jun 8, 2021

In Brief

A Phase 2 clinical trial evaluating SPD489 (Lisdexamfetamine dimesylate) and Matching placebo for Major Depressive Disorder. Completed, enrolled 143 participants across 33 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 28, 2009
Enrollment StartOct 29, 2009
Primary CompletionApr 18, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.8 years ago

Interventions

SPD489 (Lisdexamfetamine dimesylate)drug

Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily

Matching placebodrug

oral, once daily