MedTrace Logo

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

NCT00905424 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2021-06-14

Study results available
· View outcomes & findings →

Summary

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.

Conditions

Interventions

DRUG

Antidepressant + SPD489 (lisdexamfetamine dimesylate)

Escitalopram oxalate (antidepressant) 20 mg/day oral + 20, 30, or 50 mg SPD489 oral once daily for 6 weeks

DRUG

Antidepressant + placebo

Escitalopram oxalate (antidepressant) 20 mg/day oral + placebo oral once daily for 6 weeks

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-30
Primary Completion
2010-08-04
Completion
2010-08-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00905424 on ClinicalTrials.gov