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SPD489 Adult Major Depressive...

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

Last Updated: 2021-06-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-27

Study Completion Date

2014-03-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPD489 + Antidepressant

Group Type EXPERIMENTAL

SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

Intervention Type DRUG

SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks

Interventions

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SPD489 (Lisdexamfetamine dimesylate) + Antidepressant

Intervention Type DRUG

Other Intervention Names

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Vyvanse, LDX

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Medical & Behavioral Health Research, PC

New York, New York, United States

Site Status

Fieve Clinical Research

New York, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

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Richmond Behavioral Associates

Staten Island, New York, United States

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Birmingham Research Group

Birmingham, Alabama, United States

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ResearchOne, Inc.

Scottsdale, Arizona, United States

Site Status

Arkansas Psychiatric Clinical Research Trials, P.A.

Little Rock, Arkansas, United States

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South Coast Clinical Trials, Inc.

Anaheim, California, United States

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American Neuropsychiatric Research, Inc.

Carson, California, United States

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Catalina Research Institute, LLC

Chino, California, United States

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Shanti Clinical Trials

Colton, California, United States

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ATP Clinical Research

Costa Mesa, California, United States

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Clinical Innovation, Inc.

Costa Mesa, California, United States

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Diligent Clinical Trials

Downey, California, United States

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Synergy Clinical Research Center of Escondido

Escondido, California, United States

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Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

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UC, Irvine Child Development Center

Irvine, California, United States

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Irvine Center For Clinical Research

Irvine, California, United States

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Omega Clinical Trials, LLC

La Habra, California, United States

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Semel Institute for Neuroscience & Human Behavior at UCLA

Los Angeles, California, United States

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Pacific Research Partners

Oakland, California, United States

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North County Clinical Research

Oceanside, California, United States

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Pasadena Research Institute, LLC

Pasadena, California, United States

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Anderson Clinical Research

Redlands, California, United States

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