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

May 25, 2021 updated by: Shire

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1197

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405BOA
        • Instituto Nacional de Psicopatologia
      • Buenos Aires, Argentina
        • Cervino
      • Caba, Argentina, 1417
        • Centro Medico de Medicina Familiar Mind Out Research
      • Caba, Argentina, C1012AAU
        • BA Psychiatric Research Center
      • Cordoba, Argentina
        • Instituto Medico SAMIC
  • Australia
      • Elizabeth Vale, Australia, 5112
        • Lyell McEwin Hospital, Mental Health Clinical Trials Unit
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Health Mental Health Services
      • Malvern, Victoria, Australia, 3144
        • Neurotherapy Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred, Monash Alfred Psychiatry Research Centre
      • Richmond, Victoria, Australia, 3121
        • The Melbourne Clinic
  • Chile
    • Il Region
      • Antofagasta, Il Region, Chile, 1270244
        • Psocomed Estudios Medicos
    • Santiago
      • Las Condes, Santiago, Chile, 7560356
        • Especialidades Medicas L y S
      • Las Condes, Santiago, Chile, 7580307
        • Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas
      • Providencia, Santiago, Chile, 7500710
        • BioMedica Research Group
      • Providencia, Santiago, Chile, 7510186
        • Centro de Estudios Clinicos
      • San Bernardo, Santiago, Chile, 8053095
        • Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino
      • San Miguel, Santiago, Chile, 890085
        • Hospital Barros Luco Trudsau
  • United Kingdom
      • Derby, United Kingdom, DE22 3NE
        • Radbourne Unit
      • Horsham, United Kingdom, RH12 1RJ
        • ADHD Mental Health Research Unit
      • Newcastle upon Tyne, United Kingdom, NE4 5PL
        • Newcastle University, Wolfson Research Centre
      • Nottingham, United Kingdom, NG2 7PG
        • Rushcliffe Mental Health Team
    • Warrington Cheshire
      • Winwick, Warrington Cheshire, United Kingdom, WA2 8WA
        • Hollins Park Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • Arkansas Psychiatric Clinic Clinical Research Trials
    • California
      • Anaheim, California, United States, 92804
        • South Coast Clinical Trials
      • Chino, California, United States, 91710
        • Catalina Research Institute, LLC
      • Colton, California, United States, 92324
        • Shanti Clinical Trials
      • Costa Mesa, California, United States, 92626
        • Clinical Innovation, Inc.
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • Irvine, California, United States, 92618
        • Irvine Center for Clinical Research
      • La Habra, California, United States, 90631
        • Omega Clinical Trials
      • Los Angeles, California, United States, 90024
        • Provate Practice of Andrew Leuchter, MD
      • San Diego, California, United States, 92108
        • PCSD - Feighner Research
      • San Diego, California, United States, 92123
        • Artemis Institute for Clinical Research
      • Santa Ana, California, United States, 92701
        • Neuropsychiatric Research Center of Orange County
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc.
    • Colorado
      • Denver, Colorado, United States, 80209
        • Western Affiliated Research Institute
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Connecticut Clinical Research
      • Hartford, Connecticut, United States, 06106
        • Institute of Living
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Clinical Research Center
      • Gainesville, Florida, United States, 32607
        • Sarkis Clinical Trials
      • Jacksonville, Florida, United States, 32216
        • Clinical Neuroscience Solutions, Inc.
      • Jacksonville, Florida, United States, 32256
        • Private Practice - Amit Vijapura MD
      • Lake City, Florida, United States, 32025
        • Psychiatric Associates
      • Miramar, Florida, United States, 33027
        • Comprehensive NeuroScience, Inc.
      • North Miami, Florida, United States, 33161
        • Fideltiy Clinical Research, Inc.
      • Orlando, Florida, United States, 32839
        • Ali A. Kashfi, MD, PA
      • Winter Haven, Florida, United States, 33880
        • Clinical Research of Central Florida
      • Winter Park, Florida, United States, 32789
        • Kolin Research Group
    • Georgia
      • Smyrna, Georgia, United States, 30080
        • Institute For Behavioral Medicine, Llc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Treatment Research Center, Rush University Medical Center
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
      • Skokie, Illinois, United States, 60076
        • Psychiatric Medicine Associates, LLC
      • Vernon Hills, Illinois, United States, 60061
        • Sleep and Behavior Medicine Institute
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Clinical Trials Technology, Inc.
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research, LLC
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Psyichatric Care and Research Center
      • Saint Louis, Missouri, United States, 63109
        • Mid-America Clinical Research, LLC
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Premier Psychiatric Research Institute, LLC.
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Clinical Research Consortium
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Center For Emotional Fitness
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience, Inc.
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10010
        • Clinlabs, Inc.
      • New York, New York, United States, 11029
        • Mount Sinai School of Medicine
      • West Seneca, New York, United States, 14224
        • Private Practice - Daniel I. Rifkin MD PC
    • North Carolina
      • Hickory, North Carolina, United States, 28601
        • Clinical Trials of America, Inc.
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • North Coast Clinical Trials, Inc.
      • Columbus, Ohio, United States, 43210
        • Ohio State University, Dept. of Psychiatry
      • Toledo, Ohio, United States, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • West Chester, Pennsylvania, United States, 19380
        • University Services
    • Texas
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research, LLC
      • Friendswood, Texas, United States, 77546
        • Bay Area Clinical Services
      • Houston, Texas, United States, 77098
        • Houston Clinical Trials, LLC
      • Wharton, Texas, United States, 77488
        • Wharton Research Center, Inc.
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Alliance Research Group
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation for Health, Research and Education, Inc.
      • Waukesha, Wisconsin, United States, 53188
        • Independent Psychiatric Consultants, Sc, Dba, Ipc Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Subject is able to provide written, personally signed and dated informed consent to participate in the study before completing any study-related procedures.
  2. Subject is between 18-65 years of age.
  3. Subject has a primary diagnosis of non-psychotic MDD.
  4. Subject has a MADRS total score 24
  5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
  6. 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.
  7. Subject is able to swallow a capsule.

Exclusion Criteria

  1. Subject whose current episode of MDD has not responded to an adequate treatment regimen.
  2. Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.
  3. 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.
  4. Subject has been hospitalized (within the last 12 months) for their current MDD episode.
  5. Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).
  6. Subject has a first degree relative that has been diagnosed with bipolar I disorder.
  7. Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.
  8. Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
  9. Subject has a concurrent chronic or acute illness or unstable medical condition.
  10. 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.
  11. 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.
  12. 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.
  13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  14. Subject has glaucoma.
  15. Subject has any clinically significant ECG or clinical laboratory abnormalities at the Screening Visit.
  16. Subject has a history of moderate to severe hypertension.
  17. Current use of any other medication (including over-the-counter [OTC], herbal or homeopathic preparations) that has central nervous system effects.
  18. 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.
  19. Subject has had electroconvulsive therapy for the current depressive episode 3 months prior to the Lead-in Baseline Visit.
  20. The subject has a known or suspected intolerance or hypersensitivity to the investigational product.
  21. The subject has a known or suspected intolerance or hypersensitivity to any of the possible antidepressant treatments (escitalopram oxalate or venlafaxine HCL extended release.
  22. Subject has a positive urine drug result.
  23. Subject has a body mass index of <18.5 or >40.
  24. Subject is female and is pregnant or nursing.
  25. Subject has participated in another clinical study involving SPD489/NRP104 or has previously used commercial lisdexamfetamine dimesylate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Antidepressant + SPD489 10 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
Other Names:
  • Vyvanse
EXPERIMENTAL: Antidepressant + SPD489 30 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
Other Names:
  • Vyvanse
EXPERIMENTAL: Antidepressant + SPD489 50 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
Other Names:
  • Vyvanse
EXPERIMENTAL: Antidepressant + SPD489 70 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
Other Names:
  • Vyvanse
PLACEBO_COMPARATOR: Antidepressant + Placebo
Drug: Antidepressant + Placebo
oral, once daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Augmentation Baseline (Week 8) to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Time Frame: From Augmentation Baseline (Week 8) to Week 16
From Augmentation Baseline (Week 8) to Week 16
Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Time Frame: From Augmentation Baseline (Week 8) to Week 16
From Augmentation Baseline (Week 8) to Week 16
Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16
Time Frame: From Augmentation Baseline (Week 8) to Week 16
From Augmentation Baseline (Week 8) to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPD489-209
  • 2011-003615-28 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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