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Major Depressive DisorderPhase 3NCT01436149

Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

A Phase 3 study testing SPD489 (Lisdexamfetamine dimesylate ) in people with Major Depressive Disorder, run by Shire at 85 sites in 6 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?
SPD489 (Lisdexamfetamine dimesylate )
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,262 participants
Where
85 sitesin 6 countries
Study dates
27 Oct 2011to 23 Dec 2013
Phase
Phase 3
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.
  • Subject is between 18 and 65 years of age.
  • Subject has a primary diagnosis of non-psychotic MDD (single or recurrent).
  • Subject has a MADRS total score 24.
  • Subject who is female, must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test and a negative urine pregnancy test at the and agrees to comply with any applicable contraceptive requirements of the protocol.
  • Subject is able to swallow a capsule.

Who cannot join

  • Subject whose current episode of MDD has not responded to an adequate treatment regimen with 2 or more approved single antidepressant agents.
  • Subject who has a lifetime history of treatment resistant depression.
  • Subject has a current co-morbid psychiatric disorder. Excluded are: any significant Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa.
  • 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 21Show fewer
  • Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder
  • Subject is considered a suicide risk in the opinion of the Investigator, 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.
  • 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 a history of moderate to severe hypertension.
  • Current use of any other medications (including over-the-counter [OTC], herbal or homeopathic preparations) that have central nervous system effects.
  • Subject has had electroconvulsive therapy (ECT) for the current depressive episode 3 months prior.
  • The subject has a known or suspected intolerance, hypersensitivity, or contraindications to their assigned antidepressant treatments (escitalopram oxalate, sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl).
  • Subject has a positive urine drug result.
  • Subject has a body mass index (BMI) of <18.5 or >40.
  • Subject is female and is pregnant or nursing.

Trial locations and contacts

85 sites in 6 countries.

85 sites in 6 countries

United States47 sites

  • FutureSearch Clinical Trials, LP

    Austin, Texas, 78731

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • Birmingham Research Group

    Birmingham, Alabama, 35216

  • Paramount Clinical Research

    Bridgeville, Pennsylvania, 15107

  • AV Institue, Inc.

    Carson, California, 90746

  • Community Research

    Cincinnati, Ohio, 45227

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • CNS Clinical Research Group

    Coral Springs, Florida, 33067

  • Triangle Neuropsychiatry

    Durham, North Carolina, 27707

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • MCM Clinical Research LLC

    Florence, Kentucky, 41042

  • Emerald Coast Mood & Memory, PA

    Fort Walton Beach, Florida, 32547

  • Potomac Grove Clinical Research Center

    Gaithersburg, Maryland, 20877

  • Geriatric and Adult Psychiatry, LLC

    Hamden, Connecticut, 06518

  • The Davis Clinic

    Indianapolis, Indiana, 46260

  • University of California, Irvine Child Development Center

    Irvine, California, 92612

  • Florida Clinical Research Center, LLC.

    Maitland, Florida, 32751

  • Lindner Center of HOPE

    Mason, Ohio, 45040

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Middlexex Hospital Center for Behavioral Health

    Middletown, Connecticut, 06457

  • Bioscience Research, LLC

    Mount Kisco, New York, 10549

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Fieve Clinical Research

    New York, New York, 10168

  • South Coast Clinicals

    Norwalk, California, 90650

  • American Medical Research, Inc.

    Oak Brook, Illinois, 60523

  • North County Clinical Research

    Oceanside, California, 92056

  • SP Research, PLLC

    Oklahoma City, Oklahoma, 73112

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Pasadena Research Institute, LLC

    Pasadena, California, 91106

  • CRI Worldwide LLC

    Philadelphia, Pennsylvania, 19139

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15213

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Rcihard H. Weisler, MD, PA & Associates

    Raleigh, North Carolina, 27809

  • Office of Marc Hertzman, MD

    Rockville, Maryland, 20852

  • St. Charles Psychiatric Associates - Midwest Research Group

    Saint Charles, Missouri, 63301

  • Affiliated Research Institute

    San Diego, California, 92108

  • Clinical Innovations, Inc.

    San Diego, California, 92121

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Carman Research

    Smyrna, Georgia, 30080

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Northwest Indiana Center for Clinical Research

    Valparaiso, Indiana, 46383

  • Adams Clinical Trials, LLC

    Watertown, Massachusetts, 02472

Other trials in United States

Canada20 sites

  • Aggarwal & Associates Ltd.

    Brampton, Ontario, L6T 0G1

  • Depression, Mood Disorders and Schizophrenia Treatment Centre

    Burlington, Ontario, L7R 4E2

  • Chatham-Kent Clinical Trials Research Center

    Chatham, Ontario, N7M 5L9

  • Pierre-Janet Hospital

    Gatineau, Quebec, J8A1K7

  • Regional Mental Health Care

    London, Ontario, N6A 4H1

  • Anxiety and Mood Disorder Center

    Mississauga, Ontario, L5M 4N4

  • Medical Research Associates

    Mississauga, Ontario, L5M 4N4

  • l'Hopital Louis H. Lafontaine

    Montreal, Quebec, H1N 3M5

  • A.K. Karan Holdings

    Oakville, Ontario, L6J0B2

  • International Sleep Clinic, West Parry Sound Health Centre

    Parry Sound, Ontario, P2A 3A4

  • Dr. Alexander McIntyre Inc

    Penticton, British Columbia, V2A 4M4

  • Kells Medical Research Group Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Q&T Research Sherbrooke

    Sherbrooke, Quebec, J1H 4J6

  • START Clinic for Mood and Anxiety Disorders

    Toronto, Ontario, M4W 2N4

  • Univ Health Network, Toronto Western Hospital

    Toronto, Ontario, M5T2S8

  • Sleep & Alertness Clinic (Sleep & Alertness Research, Inc.)

    Toronto, Ontario, M6J 3S3

  • Manna Research

    Toronto, Ontario, M9W 4L6

  • Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.

    Vancouver, British Columbia, V6Z 2L4

  • Windsor Regional Hospital-Tayfour Campus

    Windsor, Ontario, N9C 3Z4

Other trials in Canada

Spain9 sites

  • Hospital de la Santa Creo l Sant Pau

    Barcelona, 08025

  • Hospital Universitari de Bellvitge, Servicio de Psiquiatria

    Barcelona, 08907

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Fundacion de Alcorcon

    Madrid, 28922

  • Hospital Universitario de Henares

    Madrid

  • Centro de Salud Mental Il la Corredoria

    Oviedo, 33011

  • Centro Salud Alamedilla Unidad de Salud Mental

    Salamanca, 37003

  • Complejo hospitalario de Zamora

    Zamora, 49021

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Mexico5 sites

  • Hospital Aranda de la Parra

    León, 37000

  • Centro Regiomontano de Investigacion S.C. (CRI)

    Monterrey, Nuevo León, 647-10

  • Instituto de Infromacion e Investigación en Salud Mental (INFOSAME)

    Nuevo León, 64710

  • Consultorio Especializado en Psiquiatria Infantil y Adolescentes

    San Luis Potosí City, 78200

  • B & B Investigaciones Medicas S.C.

    Sinaloa, 82126

Other trials in Mexico

Croatia2 sites

  • Poliklinika Neuron

    Zagreb, 10 000

  • Psychiatric Clinic Vrapoe

    Zagreb, 10090

Other trials in Croatia

Puerto Rico2 sites

  • Dharma Institute & Research Center

    San Juan, 00907

  • INSPIRA Clinical Research

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, 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. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). 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 supplemental SPD489 help patients who still have residual depression symptoms while 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
SPD489 (Lisdexamfetamine dimesylate ), 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.

  • SPD489 (Lisdexamfetamine dimesylate )Drug

    Also called Vyvanse

    Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks

  • PlaceboDrug

    Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks

Study groups in NCT01436149
Study groupRoleWhat they receive
Antidepressant + SPD489ExperimentalNot described
Receives: Drug: SPD489 (Lisdexamfetamine dimesylate )
Antidepressant + PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks

    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.

    Measured: 8 weeks

Secondary outcomes (11)

  1. Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks

    Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.

    Measured: 8 weeks

  2. Percentage of Participants Achieving a 25% Response on the MADRS

    The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET).

    Measured: up to 8 weeks

  3. Percentage of Participants Achieving a 50% Response on the MADRS

    The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET).

    Measured: up to 8 weeks

  4. Percentage of Participants Achieving Remission on the MADRS

    MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET).

    Measured: up to 8 weeks

  5. Mean Change From Baseline Over Time in MADRS Total Score

    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.

    Measured: Baseline and up to 8 weeks

  6. Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)

    The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms.

    Measured: up to 8 weeks

  7. Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)

    Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.

    Measured: up to 8 weeks

  8. Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)

    The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life.

    Measured: up to 8 weeks

  9. Clinical Global Impressions - Global Improvement (CGI-I)

    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.

    Measured: up to 8 weeks

  10. Columbia Suicide Severity Rating Scale (C-SSRS)

    C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale.

    Measured: up to 8 weeks

  11. Amphetamine Cessation Symptom Assessment (ACSA)

    ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.

    Measured: up to 8 weeks

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 start27 Oct 2011
  3. Primary completion23 Dec 2013
  4. Study completion23 Dec 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01436149
Sponsor's protocol ID
SPD489-322
Other IDs
2011-003018-17
Status last verified
May 2021
First submitted
15 Sep 2011
Last updated
9 Jun 2021

Publications

  • Richards C, McIntyre RS, Weisler R, Sambunaris A, Brawman-Mintzer O, Gao J, Geibel B, Dauphin M, Madhoo M. Lisdexamfetamine dimesylate augmentation for adults with major depressive disorder and inadequate response to antidepressant monotherapy: Results from 2 phase 3, multicenter, randomized, double-blind, placebo-controlled studies. J Affect Disord. 2016 Dec;206:151-160. doi: 10.1016/j.jad.2016.07.006. Epub 2016 Jul 5.

    PubMed 27474961

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPD489 (Lisdexamfetamine dimesylate ) in people with Major Depressive Disorder, run by Shire at 85 sites in 6 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 6 inclusion and 21 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 85 sites in United States, Canada, Spain, Mexico, Croatia and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Nov 2014). 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?

Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks (time frame: 8 weeks). 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 NCT01436149, 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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