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Major Depressive DisorderPhase 2NCT01435759

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

A Phase 2 study testing Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg and Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg in people with Major Depressive Disorder, run by Shire at 82 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg and Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,197 participants
Where
82 sitesin 5 countries
Study dates
31 May 2011to 17 Jan 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

82 sites in 5 countries.

82 sites in 5 countries

United States60 sites

  • Albuquerque Neuroscience, Inc.

    Albuquerque, New Mexico, 87109

  • South Coast Clinical Trials

    Anaheim, California, 92804

  • North Coast Clinical Trials, Inc.

    Beachwood, Ohio, 44122

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Treatment Research Center, Rush University Medical Center

    Chicago, Illinois, 60612

  • Catalina Research Institute, LLC

    Chino, California, 91710

  • Shanti Clinical Trials

    Colton, California, 92324

  • Ohio State University, Dept. of Psychiatry

    Columbus, Ohio, 43210

  • Clinical Innovation, Inc.

    Costa Mesa, California, 92626

  • Connecticut Clinical Research

    Cromwell, Connecticut, 06416

  • Pillar Clinical Research, LLC

    Dallas, Texas, 75243

  • Western Affiliated Research Institute

    Denver, Colorado, 80209

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • Bay Area Clinical Services

    Friendswood, Texas, 77546

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Collaborative Neuroscience Network, Inc.

    Garden Grove, California, 92845

  • Institute of Living

    Hartford, Connecticut, 06106

  • Clinical Trials of America, Inc.

    Hickory, North Carolina, 28601

  • Alexian Brothers Center for Psychiatric Research

    Hoffman Estates, Illinois, 60169

  • Houston Clinical Trials, LLC

    Houston, Texas, 77098

  • Irvine Center for Clinical Research

    Irvine, California, 92618

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • Private Practice - Amit Vijapura MD

    Jacksonville, Florida, 32256

  • Omega Clinical Trials

    La Habra, California, 90631

  • Psychiatric Associates

    Lake City, Florida, 32025

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • Premier Psychiatric Research Institute, LLC.

    Lincoln, Nebraska, 68526

  • Arkansas Psychiatric Clinic Clinical Research Trials

    Little Rock, Arkansas, 72223

  • Provate Practice of Andrew Leuchter, MD

    Los Angeles, California, 90024

  • Dean Foundation for Health, Research and Education, Inc.

    Middleton, Wisconsin, 53562

  • Comprehensive Neuroscience, Inc.

    Miramar, Florida, 33027

  • The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research

    New Britain, Connecticut, 06050

  • Clinlabs, Inc.

    New York, New York, 10010

  • Mount Sinai School of Medicine

    New York, New York, 11029

  • Fideltiy Clinical Research, Inc.

    North Miami, Florida, 33161

  • Psyichatric Care and Research Center

    O'Fallon, Missouri, 63368

  • IPS Research Company

    Oklahoma City, Oklahoma, 73103

  • Ali A. Kashfi, MD, PA

    Orlando, Florida, 32839

  • Pedia Research, LLC

    Owensboro, Kentucky, 42301

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Clinical Trials Technology, Inc.

    Prairie Village, Kansas, 66206

  • Alliance Research Group

    Richmond, Virginia, 23230

  • PCSD - Feighner Research

    San Diego, California, 92108

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California, 92701

  • California Neuroscience Research Medical Group, Inc.

    Sherman Oaks, California, 91403

  • Psychiatric Medicine Associates, LLC

    Skokie, Illinois, 60076

  • Institute for Behavioral Medicine, LLC

    Smyrna, Georgia, 30080

  • Mid-America Clinical Research, LLC

    St Louis, Missouri, 63109

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Neurology & Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Sleep and Behavior Medicine Institute

    Vernon Hills, Illinois, 60061

  • Independent Psychiatric Consultants, SC, dba, IPC Research

    Waukesha, Wisconsin, 53188

  • University Services

    West Chester, Pennsylvania, 19380

  • Private Practice - Daniel I. Rifkin MD PC

    West Seneca, New York, 14224

  • Wharton Research Center, Inc.

    Wharton, Texas, 77488

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309

  • CRI Worldwide LLC

    Willingboro, New Jersey, 08046

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

  • Kolin Research Group

    Winter Park, Florida, 32789

Other trials in United States

Chile7 sites

  • Psocomed Estudios Medicos

    Antofagasta, Il Region, 1270244

  • Especialidades Medicas L y S

    Las Condes, Santiago Metropolitan, 7560356

  • Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas

    Las Condes, Santiago Metropolitan, 7580307

  • Biomedica Research Group

    Providencia, Santiago Metropolitan, 7500710

  • Centro de Estudios Clinicos

    Providencia, Santiago Metropolitan, 7510186

  • Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino

    San Bernardo, Santiago Metropolitan, 8053095

  • Hospital Barros Luco Trudsau

    San Miguel, Santiago Metropolitan, 890085

Other trials in Chile

Argentina5 sites

  • Instituto Nacional de Psicopatologia

    Buenos Aires, C1405BOA

  • Cervino

    Buenos Aires

  • Centro Medico de Medicina Familiar Mind Out Research

    CABA, 1417

  • BA Psychiatric Research Center

    CABA, C1012AAU

  • Instituto Medico SAMIC

    Córdoba

Other trials in Argentina

Australia5 sites

  • Lyell McEwin Hospital, Mental Health Clinical Trials Unit

    Elizabeth Vale, 5112

  • Peninsula Health Mental Health Services

    Frankston, Victoria, 3199

  • Neurotherapy Victoria

    Malvern, Victoria, 3144

  • The Alfred, Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004

  • The Melbourne Clinic

    Richmond, Victoria, 3121

Other trials in Australia

United Kingdom5 sites

  • Radbourne Unit

    Derby, DE22 3NE

  • ADHD Mental Health Research Unit

    Horsham, RH12 1RJ

  • Newcastle University, Wolfson Research Centre

    Newcastle upon Tyne, NE4 5PL

  • Rushcliffe Mental Health Team

    Nottingham, NG2 7PG

  • Hollins Park Hospital

    Winwick, Warrington Cheshire, WA2 8WA

Other trials in United Kingdom

About this study

Official title: A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant

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?
Being tested
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg, Antidepressant + Placebo
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mgDrug

    Also called Vyvanse

    Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks

  • Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mgDrug

    Also called Vyvanse

    Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks

  • Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mgDrug

    Also called Vyvanse

    Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks

  • Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mgDrug

    Also called Vyvanse

    Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks

  • Antidepressant + PlaceboDrug

    oral, once daily for 8 weeks

Study groups in NCT01435759
Study groupRoleWhat they receive
Antidepressant + SPD489 10 mgExperimentalNot described
Receives: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Antidepressant + SPD489 30 mgExperimentalNot described
Receives: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Antidepressant + SPD489 50 mgExperimentalNot described
Receives: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Antidepressant + SPD489 70 mgExperimentalNot described
Receives: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Antidepressant + PlaceboPlacebo comparatorNot described
Receives: Drug: Antidepressant + Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)

    MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.

    Measured: Augmentation Baseline (Week 8) to Week 16

Secondary outcomes (3)

  1. Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16

    Measured: From Augmentation Baseline (Week 8) to Week 16

  2. Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16

    Measured: From Augmentation Baseline (Week 8) to Week 16

  3. Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16

    Measured: From Augmentation Baseline (Week 8) to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2011 (estimated)
  2. Study start31 May 2011
  3. Primary completion17 Jan 2014
  4. Study completion17 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435759
Sponsor's protocol ID
SPD489-209
Other IDs
2011-003615-28
Status last verified
May 2021
First submitted
15 Sep 2011
Last updated
9 Jun 2021

Publications

  • Richards C, Iosifescu DV, Mago R, Sarkis E, Reynolds J, Geibel B, Dauphin M. A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy. J Psychopharmacol. 2017 Sep;31(9):1190-1203. doi: 10.1177/0269881117722998. Epub 2017 Aug 31.

    PubMed 28857719

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg and Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg in people with Major Depressive Disorder, run by Shire at 82 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Chile, Argentina, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set) (time frame: Augmentation Baseline (Week 8) to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01435759, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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