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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435759
• Other study ID #: SPD489-209
• Secondary ID: 2011-003615-28
• Status: Completed
• Phase: Phase 2
• Start date: May 31, 2011
• Est. completion date: January 17, 2014

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1197
• Est. completion date: January 17, 2014
• Est. primary completion date: January 17, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
• Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
• Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
• Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
• Antidepressant + Placebo
oral, once daily for 8 weeks

Locations

Country	Name	City	State
Argentina	Cervino	Buenos Aires
Argentina	Instituto Nacional de Psicopatologia	Buenos Aires
Argentina	BA Psychiatric Research Center	Caba
Argentina	Centro Medico de Medicina Familiar Mind Out Research	Caba
Argentina	Instituto Medico SAMIC	Cordoba
Australia	Lyell McEwin Hospital, Mental Health Clinical Trials Unit	Elizabeth Vale
Australia	Peninsula Health Mental Health Services	Frankston	Victoria
Australia	Neurotherapy Victoria	Malvern	Victoria
Australia	The Alfred, Monash Alfred Psychiatry Research Centre	Melbourne	Victoria
Australia	The Melbourne Clinic	Richmond	Victoria
Chile	Psocomed Estudios Medicos	Antofagasta	Il Region
Chile	Centro de Estudios y Tratemiento de Enfermedades Psiquiatricas	Las Condes	Santiago
Chile	Especialidades Medicas L y S	Las Condes	Santiago
Chile	Biomedica Research Group	Providencia	Santiago
Chile	Centro de Estudios Clinicos	Providencia	Santiago
Chile	Unidad de Salud Mental y Psiquietriea Hospital y CRS El Pino	San Bernardo	Santiago
Chile	Hospital Barros Luco Trudsau	San Miguel	Santiago
United Kingdom	Radbourne Unit	Derby
United Kingdom	ADHD Mental Health Research Unit	Horsham
United Kingdom	Newcastle University, Wolfson Research Centre	Newcastle upon Tyne
United Kingdom	Rushcliffe Mental Health Team	Nottingham
United Kingdom	Hollins Park Hospital	Winwick	Warrington Cheshire
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	South Coast Clinical Trials	Anaheim	California
United States	North Coast Clinical Trials, Inc.	Beachwood	Ohio
United States	Montefiore Medical Center	Bronx	New York
United States	Center for Emotional Fitness	Cherry Hill	New Jersey
United States	Treatment Research Center, Rush University Medical Center	Chicago	Illinois
United States	Catalina Research Institute, LLC	Chino	California
United States	Shanti Clinical Trials	Colton	California
United States	Ohio State University, Dept. of Psychiatry	Columbus	Ohio
United States	Clinical Innovation, Inc.	Costa Mesa	California
United States	Connecticut Clinical Research	Cromwell	Connecticut
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	Western Affiliated Research Institute	Denver	Colorado
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Bay Area Clinical Services	Friendswood	Texas
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Institute of Living	Hartford	Connecticut
United States	Clinical Trials of America, Inc.	Hickory	North Carolina
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Houston Clinical Trials, LLC	Houston	Texas
United States	Irvine Center for Clinical Research	Irvine	California
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Private Practice - Amit Vijapura MD	Jacksonville	Florida
United States	Omega Clinical Trials	La Habra	California
United States	Psychiatric Associates	Lake City	Florida
United States	Clinical Research Consortium	Las Vegas	Nevada
United States	Premier Psychiatric Research Institute, LLC.	Lincoln	Nebraska
United States	Arkansas Psychiatric Clinic Clinical Research Trials	Little Rock	Arkansas
United States	Provate Practice of Andrew Leuchter, MD	Los Angeles	California
United States	Dean Foundation for Health, Research and Education, Inc.	Middleton	Wisconsin
United States	Comprehensive Neuroscience, Inc.	Miramar	Florida
United States	The Hospital of Central Connecticut, Psychiatry & Behavioral Health Research	New Britain	Connecticut
United States	Clinlabs, Inc.	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Fideltiy Clinical Research, Inc.	North Miami	Florida
United States	Psyichatric Care and Research Center	O'Fallon	Missouri
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Ali A. Kashfi, MD, PA	Orlando	Florida
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	Alliance Research Group	Richmond	Virginia
United States	Mid-America Clinical Research, LLC	Saint Louis	Missouri
United States	Artemis Institute for Clinical Research	San Diego	California
United States	PCSD - Feighner Research	San Diego	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	California Neuroscience Research Medical Group, Inc.	Sherman Oaks	California
United States	Psychiatric Medicine Associates, LLC	Skokie	Illinois
United States	Institute for Behavioral Medicine, LLC	Smyrna	Georgia
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
United States	Sleep and Behavior Medicine Institute	Vernon Hills	Illinois
United States	Independent Psychiatric Consultants, SC, dba, IPC Research	Waukesha	Wisconsin
United States	University Services	West Chester	Pennsylvania
United States	Private Practice - Daniel I. Rifkin MD PC	West Seneca	New York
United States	Wharton Research Center, Inc.	Wharton	Texas
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas
United States	CRI Worldwide LLC	Willingboro	New Jersey
United States	Clinical Research of Central Florida	Winter Haven	Florida
United States	Kolin Research Group	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Chile,  United Kingdom, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery-?sberg 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	Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16		From Augmentation Baseline (Week 8) to Week 16
Secondary	Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16		From Augmentation Baseline (Week 8) to Week 16
Secondary	Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16		From Augmentation Baseline (Week 8) to Week 16