CompletedPhase 2

SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

United States143 participantsStarted 2009-10-29

Plain-language 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).

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion Criteria: * Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression Exclusion Criteria: * Current co-morbid psychiatric disorder

What they're measuring

Change From Baseline in Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at Week 9, Last Observation Carried Forward (LOCF)

Timeframe: Baseline and week 9

Trial details

NCT IDNCT00985725

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-04-18

Results submitted2012-02-07

View on ClinicalTrials.gov More Major Depressive Disorder trials