SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. The purpose of this study is to help answer the following questions: * How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it? * Can SPD489 help patients with depression who are also taking an antidepressant? * How much SPD489 should be given to patients with depression who are also taking an antidepressant? * How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?

Key facts

Study ID: NCT01435759
Run by: Shire
People needed: 1197
Starts: 2011-05-31
Expected to finish: 2014-01-17
Last updated by the study team: 2021-06-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is able to provide written, personally signed and dated informed consent to participate in the study before completing any study-related procedures.
Subject is between 18-65 years of age.
Subject has a primary diagnosis of non-psychotic MDD.
Subject has a MADRS total score 24
Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
Subject, who is female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any applicable contraceptive requirements.
Subject is able to swallow a capsule.

You may not qualify if…

Subject whose current episode of MDD has not responded to an adequate treatment regimen.
Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.
Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms.
Subject has been hospitalized (within the last 12 months) for their current MDD episode.
Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).
Subject has a first degree relative that has been diagnosed with bipolar I disorder.
Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.
Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
Subject has a concurrent chronic or acute illness or unstable medical condition.
Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions.
Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit.
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has glaucoma.
Subject has any clinically significant ECG or clinical laboratory abnormalities at the Screening Visit.
Subject has a history of moderate to severe hypertension.
Current use of any other medication (including over-the-counter [OTC], herbal or homeopathic preparations) that has central nervous system effects.
Subject has the potential to need to initiate or modify frequency of psychotherapy or to continue or initiate other treatments for depression, outside of those allowed in this protocol.
Subject has had electroconvulsive therapy for the current depressive episode 3 months prior to the Lead-in Baseline Visit.
The subject has a known or suspected intolerance or hypersensitivity to the investigational product.
The subject has a known or suspected intolerance or hypersensitivity to any of the possible antidepressant treatments (escitalopram oxalate or venlafaxine HCL extended release.
Subject has a positive urine drug result.
Subject has a body mass index of <18.5 or >40.
Subject is female and is pregnant or nursing.
Subject has participated in another clinical study involving SPD489/NRP104 or has previously used commercial lisdexamfetamine dimesylate.

Where it is running

South Coast Clinical Trials — Anaheim, California, United States
Catalina Research Institute, LLC — Chino, California, United States
Shanti Clinical Trials — Colton, California, United States
Clinical Innovation, Inc. — Costa Mesa, California, United States
Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
Irvine Center for Clinical Research — Irvine, California, United States
Omega Clinical Trials — La Habra, California, United States
Provate Practice of Andrew Leuchter, MD — Los Angeles, California, United States
PCSD - Feighner Research — San Diego, California, United States
Artemis Institute for Clinical Research — San Diego, California, United States
Neuropsychiatric Research Center of Orange County — Santa Ana, California, United States
California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
Western Affiliated Research Institute — Denver, Colorado, United States
Connecticut Clinical Research — Cromwell, Connecticut, United States
Institute of Living — Hartford, Connecticut, United States
The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research — New Britain, Connecticut, United States
Gulfcoast Clinical Research Center — Fort Myers, Florida, United States
Sarkis Clinical Trials — Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
Private Practice - Amit Vijapura MD — Jacksonville, Florida, United States
Psychiatric Associates — Lake City, Florida, United States
Comprehensive Neuroscience, Inc. — Miramar, Florida, United States
Fideltiy Clinical Research, Inc. — North Miami, Florida, United States
Ali A. Kashfi, MD, PA — Orlando, Florida, United States
Arkansas Psychiatric Clinic Clinical Research Trials — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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