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

Shire

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Matching placebo; Drug: SPD489 (Lisdexamfetamine dimesylate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985725

SPD489-205

Details and patient eligibility

About

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).

Enrollment: 143 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18-55 with a primary diagnosis of nonpsychotic uni-polar depression

Exclusion criteria

• Current co-morbid psychiatric disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

SPD489

Treatment:

Drug: SPD489 (Lisdexamfetamine dimesylate)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Matching placebo