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

NCT00985725 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2021-06-08

Study results available
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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).

Conditions

Interventions

DRUG

SPD489 (Lisdexamfetamine dimesylate)

Oral, 20, 30, 40, 50, 60, and 70mg capsules, once daily

DRUG

Matching placebo

oral, once daily

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
2009-10-29
Primary Completion
2011-04-18
Completion
2011-04-18

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 NCT00985725 on ClinicalTrials.gov