SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
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
2 other identifiers
interventional
1,197
5 countries
82
Brief 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. 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started May 2011
Typical duration for phase_2 major-depressive-disorder
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2011
CompletedFirst Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2014
CompletedResults Posted
Study results publicly available
February 19, 2015
CompletedJune 9, 2021
May 1, 2021
2.6 years
September 15, 2011
February 3, 2015
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (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.
Augmentation Baseline (Week 8) to Week 16
Secondary Outcomes (3)
Change in Average Systolic Blood Pressure 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
From Augmentation Baseline (Week 8) to Week 16
Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16
From Augmentation Baseline (Week 8) to Week 16
Study Arms (5)
Antidepressant + SPD489 10 mg
EXPERIMENTALAntidepressant + SPD489 30 mg
EXPERIMENTALAntidepressant + SPD489 50 mg
EXPERIMENTALAntidepressant + SPD489 70 mg
EXPERIMENTALAntidepressant + Placebo
PLACEBO COMPARATORInterventions
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
Eligibility Criteria
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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (82)
Arkansas Psychiatric Clinic Clinical Research Trials
Little Rock, Arkansas, 72223, United States
South Coast Clinical Trials
Anaheim, California, 92804, United States
Catalina Research Institute, LLC
Chino, California, 91710, United States
Shanti Clinical Trials
Colton, California, 92324, United States
Clinical Innovation, Inc.
Costa Mesa, California, 92626, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Irvine Center for Clinical Research
Irvine, California, 92618, United States
Omega Clinical Trials
La Habra, California, 90631, United States
Provate Practice of Andrew Leuchter, MD
Los Angeles, California, 90024, United States
PCSD - Feighner Research
San Diego, California, 92108, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Connecticut Clinical Research
Cromwell, Connecticut, 06416, United States
Institute of Living
Hartford, Connecticut, 06106, United States
The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research
New Britain, Connecticut, 06050, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Private Practice - Amit Vijapura MD
Jacksonville, Florida, 32256, United States
Psychiatric Associates
Lake City, Florida, 32025, United States
Comprehensive Neuroscience, Inc.
Miramar, Florida, 33027, United States
Fideltiy Clinical Research, Inc.
North Miami, Florida, 33161, United States
Ali A. Kashfi, MD, PA
Orlando, Florida, 32839, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Kolin Research Group
Winter Park, Florida, 32789, United States
Institute for Behavioral Medicine, LLC
Smyrna, Georgia, 30080, United States
Treatment Research Center, Rush University Medical Center
Chicago, Illinois, 60612, United States
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
Psychiatric Medicine Associates, LLC
Skokie, Illinois, 60076, United States
Sleep and Behavior Medicine Institute
Vernon Hills, Illinois, 60061, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Psyichatric Care and Research Center
O'Fallon, Missouri, 63368, United States
Mid-America Clinical Research, LLC
St Louis, Missouri, 63109, United States
Premier Psychiatric Research Institute, LLC.
Lincoln, Nebraska, 68526, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
CRI Worldwide LLC
Willingboro, New Jersey, 08046, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
Clinlabs, Inc.
New York, New York, 10010, United States
Mount Sinai School of Medicine
New York, New York, 11029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Private Practice - Daniel I. Rifkin MD PC
West Seneca, New York, 14224, United States
Clinical Trials of America, Inc.
Hickory, North Carolina, 28601, United States
North Coast Clinical Trials, Inc.
Beachwood, Ohio, 44122, United States
Ohio State University, Dept. of Psychiatry
Columbus, Ohio, 43210, United States
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University Services
West Chester, Pennsylvania, 19380, United States
Pillar Clinical Research, LLC
Dallas, Texas, 75243, United States
Bay Area Clinical Services
Friendswood, Texas, 77546, United States
Houston Clinical Trials, LLC
Houston, Texas, 77098, United States
Wharton Research Center, Inc.
Wharton, Texas, 77488, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Alliance Research Group
Richmond, Virginia, 23230, United States
Dean Foundation for Health, Research and Education, Inc.
Middleton, Wisconsin, 53562, United States
Independent Psychiatric Consultants, SC, dba, IPC Research
Waukesha, Wisconsin, 53188, United States
Instituto Nacional de Psicopatologia
Buenos Aires, C1405BOA, Argentina
Cervino
Buenos Aires, Argentina
Centro Medico de Medicina Familiar Mind Out Research
CABA, 1417, Argentina
BA Psychiatric Research Center
CABA, C1012AAU, Argentina
Instituto Medico SAMIC
Córdoba, Argentina
Peninsula Health Mental Health Services
Frankston, Victoria, 3199, Australia
Neurotherapy Victoria
Malvern, Victoria, 3144, Australia
The Alfred, Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004, Australia
The Melbourne Clinic
Richmond, Victoria, 3121, Australia
Lyell McEwin Hospital, Mental Health Clinical Trials Unit
Elizabeth Vale, 5112, Australia
Psocomed Estudios Medicos
Antofagasta, Il Region, 1270244, Chile
Especialidades Medicas L y S
Las Condes, Santiago Metropolitan, 7560356, Chile
Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas
Las Condes, Santiago Metropolitan, 7580307, Chile
Biomedica Research Group
Providencia, Santiago Metropolitan, 7500710, Chile
Centro de Estudios Clinicos
Providencia, Santiago Metropolitan, 7510186, Chile
Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino
San Bernardo, Santiago Metropolitan, 8053095, Chile
Hospital Barros Luco Trudsau
San Miguel, Santiago Metropolitan, 890085, Chile
Hollins Park Hospital
Winwick, Warrington Cheshire, WA2 8WA, United Kingdom
Radbourne Unit
Derby, DE22 3NE, United Kingdom
ADHD Mental Health Research Unit
Horsham, RH12 1RJ, United Kingdom
Newcastle University, Wolfson Research Centre
Newcastle upon Tyne, NE4 5PL, United Kingdom
Rushcliffe Mental Health Team
Nottingham, NG2 7PG, United Kingdom
Related Publications (1)
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.
PMID: 28857719RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2011
First Posted
September 19, 2011
Study Start
May 31, 2011
Primary Completion
January 17, 2014
Study Completion
January 17, 2014
Last Updated
June 9, 2021
Results First Posted
February 19, 2015
Record last verified: 2021-05