Back to resultsSPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Sites / Locations
- Arkansas Psychiatric Clinic Clinical Research Trials
- South Coast Clinical Trials
- Catalina Research Institute, LLC
- Shanti Clinical Trials
- Clinical Innovation, Inc.
- Collaborative Neuroscience Network, Inc.
- Irvine Center for Clinical Research
- Omega Clinical Trials
- Provate Practice of Andrew Leuchter, MD
- PCSD - Feighner Research
- Artemis Institute for Clinical Research
- Neuropsychiatric Research Center of Orange County
- California Neuroscience Research Medical Group, Inc.
- Western Affiliated Research Institute
- Connecticut Clinical Research
- Institute of Living
- The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research
- Gulfcoast Clinical Research Center
- Sarkis Clinical Trials
- Clinical Neuroscience Solutions, Inc.
- Private Practice - Amit Vijapura MD
- Psychiatric Associates
- Comprehensive Neuroscience, Inc.
- Fideltiy Clinical Research, Inc.
- Ali A. Kashfi, MD, PA
- Clinical Research of Central Florida
- Kolin Research Group
- Institute for Behavioral Medicine, LLC
- Treatment Research Center, Rush University Medical Center
- Alexian Brothers Center for Psychiatric Research
- Psychiatric Medicine Associates, LLC
- Sleep and Behavior Medicine Institute
- Clinical Trials Technology, Inc.
- Pedia Research, LLC
- Psyichatric Care and Research Center
- Mid-America Clinical Research, LLC
- Premier Psychiatric Research Institute, LLC.
- Clinical Research Consortium
- Center for Emotional Fitness
- CRI Worldwide LLC
- Albuquerque Neuroscience, Inc.
- Montefiore Medical Center
- Clinlabs, Inc.
- Mount Sinai School of Medicine
- Private Practice - Daniel I. Rifkin MD PC
- Clinical Trials of America, Inc.
- North Coast Clinical Trials, Inc.
- Ohio State University, Dept. of Psychiatry
- Neurology & Neuroscience Center of Ohio
- IPS Research Company
- Thomas Jefferson University
- University Services
- Pillar Clinical Research, LLC
- Bay Area Clinical Services
- Houston Clinical Trials, LLC
- Wharton Research Center, Inc.
- Grayline Clinical Drug Trials
- Alliance Research Group
- Dean Foundation for Health, Research and Education, Inc.
- Independent Psychiatric Consultants, SC, dba, IPC Research
- Instituto Nacional de Psicopatologia
- Cervino
- Centro Medico de Medicina Familiar Mind Out Research
- BA Psychiatric Research Center
- Instituto Medico SAMIC
- Peninsula Health Mental Health Services
- Neurotherapy Victoria
- The Alfred, Monash Alfred Psychiatry Research Centre
- The Melbourne Clinic
- Lyell McEwin Hospital, Mental Health Clinical Trials Unit
- Psocomed Estudios Medicos
- Especialidades Medicas L y S
- Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas
- Biomedica Research Group
- Centro de Estudios Clinicos
- Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino
- Hospital Barros Luco Trudsau
- Hollins Park Hospital
- Radbourne Unit
- ADHD Mental Health Research Unit
- Newcastle University, Wolfson Research Centre
- Rushcliffe Mental Health Team
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Antidepressant + SPD489 10 mg
Antidepressant + SPD489 30 mg
Antidepressant + SPD489 50 mg
Antidepressant + SPD489 70 mg
Antidepressant + Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01435759
Brief Title
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2011 (Actual)
Primary Completion Date
January 17, 2014 (Actual)
Study Completion Date
January 17, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antidepressant + SPD489 10 mg
Arm Type
Experimental
Arm Title
Antidepressant + SPD489 30 mg
Arm Type
Experimental
Arm Title
Antidepressant + SPD489 50 mg
Arm Type
Experimental
Arm Title
Antidepressant + SPD489 70 mg
Arm Type
Experimental
Arm Title
Antidepressant + Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Other Intervention Name(s)
Vyvanse
Intervention Description
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Antidepressant + Placebo
Intervention Description
oral, once daily for 8 weeks
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Augmentation Baseline (Week 8) to Week 16
Secondary Outcome Measure Information:
Title
Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Time Frame
From Augmentation Baseline (Week 8) to Week 16
Title
Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16
Time Frame
From Augmentation Baseline (Week 8) to Week 16
Title
Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16
Time Frame
From Augmentation Baseline (Week 8) to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Psychiatric Clinic Clinical Research Trials
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
South Coast Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Shanti Clinical Trials
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
Facility Name
Clinical Innovation, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Irvine Center for Clinical Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Omega Clinical Trials
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
Facility Name
Provate Practice of Andrew Leuchter, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
PCSD - Feighner Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Western Affiliated Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Connecticut Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Private Practice - Amit Vijapura MD
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Psychiatric Associates
City
Lake City
State/Province
Florida
ZIP/Postal Code
32025
Country
United States
Facility Name
Comprehensive Neuroscience, Inc.
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Fideltiy Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Ali A. Kashfi, MD, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32839
Country
United States
Facility Name
Clinical Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Kolin Research Group
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Institute for Behavioral Medicine, LLC
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Treatment Research Center, Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Psychiatric Medicine Associates, LLC
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Sleep and Behavior Medicine Institute
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Clinical Trials Technology, Inc.
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Pedia Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Psyichatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Mid-America Clinical Research, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Premier Psychiatric Research Institute, LLC.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Center for Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
CRI Worldwide LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Clinlabs, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
11029
Country
United States
Facility Name
Private Practice - Daniel I. Rifkin MD PC
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
North Coast Clinical Trials, Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Ohio State University, Dept. of Psychiatry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology & Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University Services
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Bay Area Clinical Services
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Houston Clinical Trials, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Wharton Research Center, Inc.
City
Wharton
State/Province
Texas
ZIP/Postal Code
77488
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Alliance Research Group
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Dean Foundation for Health, Research and Education, Inc.
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Independent Psychiatric Consultants, SC, dba, IPC Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Instituto Nacional de Psicopatologia
City
Buenos Aires
ZIP/Postal Code
C1405BOA
Country
Argentina
Facility Name
Cervino
City
Buenos Aires
Country
Argentina
Facility Name
Centro Medico de Medicina Familiar Mind Out Research
City
Caba
ZIP/Postal Code
1417
Country
Argentina
Facility Name
BA Psychiatric Research Center
City
Caba
ZIP/Postal Code
C1012AAU
Country
Argentina
Facility Name
Instituto Medico SAMIC
City
Cordoba
Country
Argentina
Facility Name
Peninsula Health Mental Health Services
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Neurotherapy Victoria
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
The Alfred, Monash Alfred Psychiatry Research Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
The Melbourne Clinic
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Lyell McEwin Hospital, Mental Health Clinical Trials Unit
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Facility Name
Psocomed Estudios Medicos
City
Antofagasta
State/Province
Il Region
ZIP/Postal Code
1270244
Country
Chile
Facility Name
Especialidades Medicas L y S
City
Las Condes
State/Province
Santiago
ZIP/Postal Code
7560356
Country
Chile
Facility Name
Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas
City
Las Condes
State/Province
Santiago
ZIP/Postal Code
7580307
Country
Chile
Facility Name
Biomedica Research Group
City
Providencia
State/Province
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Centro de Estudios Clinicos
City
Providencia
State/Province
Santiago
ZIP/Postal Code
7510186
Country
Chile
Facility Name
Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino
City
San Bernardo
State/Province
Santiago
ZIP/Postal Code
8053095
Country
Chile
Facility Name
Hospital Barros Luco Trudsau
City
San Miguel
State/Province
Santiago
ZIP/Postal Code
890085
Country
Chile
Facility Name
Hollins Park Hospital
City
Winwick
State/Province
Warrington Cheshire
ZIP/Postal Code
WA2 8WA
Country
United Kingdom
Facility Name
Radbourne Unit
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
ADHD Mental Health Research Unit
City
Horsham
ZIP/Postal Code
RH12 1RJ
Country
United Kingdom
Facility Name
Newcastle University, Wolfson Research Centre
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Rushcliffe Mental Health Team
City
Nottingham
ZIP/Postal Code
NG2 7PG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28857719
Citation
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.
Results Reference
result
Learn more about this trial
SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
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