Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

Shire

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Antidepressant + placebo; Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00905424

SPD489-203

Details and patient eligibility

About

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.

Enrollment: 246 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 MDD

Exclusion criteria

• History of non-response to multiple antidepressants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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246 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Antidepressant + SPD489

Treatment:

Drug: Antidepressant + SPD489 (lisdexamfetamine dimesylate)

Placebo

Placebo Comparator group

Description:

Antidepressant + placebo

Treatment:

Drug: Antidepressant + placebo