SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

Shire

Status and phase: Terminated; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436175

SPD489-329

2011-003019-47 (EudraCT Number)

Details and patient eligibility

About

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.

Enrollment: 1,570 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.

Exclusion criteria

• Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,570 participants in 1 patient group

SPD489 + Antidepressant

Experimental group

Treatment:

Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant