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Major Depressive DisorderPhase 3NCT01436162

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 Antidepressant + SPD489 (Lisdexamfetamine dimesylate ) in people with Major Depressive Disorder, run by Shire at 101 sites in 11 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 )
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,105 participants
Where
101 sitesin 11 countries
Study dates
19 Oct 2011to 10 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 before completing any study-related procedures.
  • Subject is between 18 and 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 (B-HCG) pregnancy test and a negative urine pregnancy test 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, defined as having not responded to adequate treatment with 2 or more treatment regimens.
  • Subject has a current co-morbid 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 24Show 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.
  • 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.
  • 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 the potential 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 (ECT) 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, 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

101 sites in 11 countries.

101 sites in 11 countries

United States36 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Atlanta Institute of Medicine & Research

    Atlanta, Georgia, 30328

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34201

  • Brooklyn Medical Institute

    Brooklyn, New York, 11214

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • KRK Medical Research

    Dallas, Texas, 75230

  • Future Search Trials of Dallas, LP

    Dallas, Texas, 75231

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • Diligent Clinical Trials

    Downey, California, 90241

  • Synergy Clinical Reserach Center of Escondido

    Escondido, California, 92025

  • Psychiatric Consultants, PC

    Franklin, Tennessee, 37067

  • Comprehensive Psychiatric Associates

    Gladstone, Missouri, 64118

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • K&S Professional Research Services, LLC

    Little Rock, Arkansas, 72201

  • Research Strategies of Memphis, LLC

    Memphis, Tennessee, 38119

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130

  • Medical & Behavioral Health Research, PC

    New York, New York, 10023

  • Pedia Research

    Newburgh, Indiana, 47630

  • Medical University South Carolina Anxiety Disorder Program

    North Charleston, South Carolina, 29406

  • Scientific Clinical Research, Inc.

    North Miami, Florida, 33161

  • Pacific Research Partners, LLC

    Oakland, California, 94612

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Belmont Center for Comprehensive Treatment

    Philadelphia, Pennsylvania, 19131

  • Anderson Clinical Research

    Redlands, California, 92374

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • BreakThrough Clinical Trials, LLC

    San Bernardino, California, 92408

  • ResearchOne, Inc.

    Scottsdale, Arizona, 85251

  • Louisiana Clinical Research, LLC

    Shreveport, Louisiana, 71115

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Comprehensive NeuroScience, Inc.

    St. Petersburg, Florida, 33716

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Janus Center for Psychiatric Research

    West Palm Beach, Florida, 33407

  • Heartland Research Associates

    Wichita, Kansas, 67207

Other trials in United States

Germany14 sites

  • Gemeinschafstpraxis für Neurologie und Psychiatrie, Psychotherapie

    Achim, 28832

  • Private Praxis Dr. Jana Thomsen

    Berlin, 10245

  • emovis GmbH

    Berlin, 10629

  • Alexander Schulze, MD

    Berlin, 13156

  • Private Practice Drs. Bitter/Schumann

    Bochum, 44805

  • University Hospital Carl Gustav Carus

    Dresden, 01307

  • ZSL Zentrum fuer medizinische Studien in Leipzig

    Leipzig, 04157

  • Studienzentrum Muenchen

    München, 80333

  • Universitaetsklinikum Munster

    Münster, 48149

  • Studienzentrum Klinikum Nuernberg

    Nuremberg, 90419

  • Somni bene GmbH

    Schwerin, 19053

  • Private Practice: Eugen Schlegel

    Siegen, 57072

  • Studiezentrum Nord-West

    Westerstede, 26655

  • Medizinisches Studienzentrum Wuerzburg

    Würzburg, 97070

Other trials in Germany

Czechia9 sites

  • Saint Anne s.r.o.

    Brno, 60200

  • Psychiatricka ambulance

    Brno, 615 00

  • Medicana s.r.o.

    Hořovice, 268 01

  • Psychiatrie s.r.o.

    Kutná Hora, 284 01

  • Bialbi s.r.o.

    Litoměřice, 41201

  • Clintrial s.r.o.

    Prague, 10000

  • Psychiatry Trial s.r.o.

    Prague, 15800

  • Prague Medical Services s.r.o.

    Prague, 160 00

  • Ricany s.r.o.

    Říčany, 251 01

Other trials in Czechia

Poland9 sites

  • Prywatne Gabinety Lekarskie "Promedicus"

    Bialystok, 15-879

  • NZOZ Centrum Kultury, Higieny i Zdrowia Psychicznego

    Bydgoszcz, 85-156

  • Zespol Opieki Zdrowotnej w Chelmnie

    Chełmno, 86-200

  • Centrum Badan Klinicznuch Pl-House sp. z.o.o.

    Gdansk, 80-546

  • Klinika Chorob Psychicznych i Zaburzen Nerwicowych

    Gdansk, 80-952

  • Centrum Psychiatrii i Psychoterapli

    Gorlice, 38-300

  • NZOZ Syntonia, Poradnia Zdrowia Psychicznego

    Kielce, 25-317

  • Osrodek Badafi Klinicznych Prof dr hab n med Meszek Szczepanski Prywatna Praktyka Lekarska

    Lublin, 20-022

  • Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Zurominie

    Żuromin, 09-300

Other trials in Poland

Romania6 sites

  • Spitatul Clinic Judetean de Urgenta Arad, Clinica de Psihiatrie

    Arad, 310022

  • Stefi-Dent SRL

    Botoșani, 710107

  • Spitalui Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia" Sectia Clinica Psihiatrie I

    Bucharest, 041915

  • Crucea Alba

    Oradea, 410163

  • Lorentina 2201 SRL

    Targoviste, 130081

  • Spitalul Clinic Judetean Mures

    Târgu Mureş, 540095

Other trials in Romania

South Africa6 sites

  • Cape Trial Centre

    Bellville, Cape Town, 7530

  • Flexivest Fourteen Research Centre

    Bellville, Cape Town, 7530

  • Vista Clinic

    Centurion, 0046

  • George Medi Clinic Extension

    George, 6529

  • Private Practice - Gerta Brink

    Johannesburg, Gauten, 2195

  • Somerset West Clinical Research

    Somerset West, Western Cape

Other trials in South Africa

Sweden6 sites

  • SU/ Affektiva 1

    Gothenburg, 41685

  • ProbarE i Lund AB

    Lund, 22222

  • Ekdahl Medical AB

    Malmö, 21153

  • INM Psykiatrisk Mottagning

    Malmö, 21153

  • Medinstructor Lippitz AB

    Stockholm, 11486

  • Dr. Wahlstedts mottagning

    Uppsala, 75310

Other trials in Sweden

Estonia5 sites

  • Parnu Hospital, Psychiatric Clinic

    Pärnu, 80012

  • North Estonia Medical Centre Foundation Psychiatry Clinic

    Tallinn, 10614

  • Marienthal Psychiatry and Psychology Center

    Tallinn, 10617

  • Jaanson & Laane OU

    Tartu, 50406

  • Tartu University Hospital Psychiatric Clinic

    Tartu, 50417

Other trials in Estonia

Hungary5 sites

  • Semmelweis Univ. Dept.of Psychiatry

    Budapest, 1083

  • Debrecent Egyetem Orvos es Egeszsegtudomanyl Centrum Pszichiatrai

    Debrecen, H-4032

  • Santha Kalman Mentalis Egeszsegkozpont es Szakkorhaz

    Nagykálló, 4320

  • Josa Andras Teaching Hospital

    Nyíregyháza, H-4400

  • Pecsi Tudomanyegyeiem Pszichiatriai es Pszichoterapias Klinika

    Sziget

Other trials in Hungary

Finland4 sites

  • ARTES Psykiatrinen Palvelukeskus Oy

    Helsinki, 00100

  • Satucon Oy

    Kuopio, 70100

  • Satakunnan Psykiatripalveiu Oy at Mentoria Oy

    Tampere, 26200

  • Puutorin Psykiatripalvelu

    Turku, 20100

Other trials in Finland

Belgium1 site

  • Dr Lieven De Weirdt

    Sint-Niklaas, 9100

Other trials in Belgium

About this study

Official title: The SPD489-323 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
Antidepressant + SPD489 (Lisdexamfetamine dimesylate ), 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 )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

  • Antidepressant + 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 NCT01436162
Study groupRoleWhat they receive
Antidepressant + SPD489ExperimentalNot described
Receives: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
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. Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 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 (13)

  1. Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 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 the Lead-in Baseline, Visit 2).

    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 the Lead-in Baseline, Visit 2).

    Measured: Up to 8 weeks

  4. Percent of Participants Achieving Remission on the MADRS

    MADRS remission was defined as a MADRS total score of ≤10.

    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: Up to 8 weeks

  6. Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores

    The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed.

    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 in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male

    The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.

    Measured: Up to 8 weeks

  9. Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female

    The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.

    Measured: Up to 8 weeks

  10. 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

  11. Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI)

    MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.

    Measured: Up to 8 weeks

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

    C-SSRS is a semi-structured interview that captures the occurence, 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 behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.

    Measured: Up to 8 weeks

  13. Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score

    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: 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 start19 Oct 2011
  3. Primary completion10 Dec 2013
  4. Study completion10 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
1,105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01436162
Sponsor's protocol ID
SPD489-323
Other IDs
2011-003006-25
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 Antidepressant + SPD489 (Lisdexamfetamine dimesylate ) in people with Major Depressive Disorder, run by Shire at 101 sites in 11 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 24 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 101 sites in United States, Germany, Czechia, Poland, Romania and 6 more countries. 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 7 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 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 NCT01436162, 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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