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Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: SPD489 (Lisdexamfetamine dimesylate ) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Madhukar H Trivedi, M.D., Principal Investigator, Affiliation: University of Texas Southwestern Medical School, Dallas, Texas 75235

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. 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?

Clinical Details

Official title: The SPD489-322 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks

Secondary outcome:

Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks

Percentage of Participants Achieving a 25% Response on the MADRS

Percentage of Participants Achieving a 50% Response on the MADRS

Percentage of Participants Achieving Remission on the MADRS

Mean Change From Baseline Over Time in MADRS Total Score

Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)

Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)

Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)

Clinical Global Impressions - Global Improvement (CGI-I)

Columbia Suicide Severity Rating Scale (C-SSRS)

Amphetamine Cessation Symptom Assessment (ACSA)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is able to provide written, personally signed, and dated informed consent to

participate in the study.

- Subject is between 18 and 65 years of age.

- Subject has a primary diagnosis of non-psychotic MDD (single or recurrent).

- Subject has a MADRS total score 24.

- Subject who is female, must have a negative serum beta human chorionic gonadotropin

(HCG) pregnancy test and a negative urine pregnancy test at the and agrees to comply with any applicable contraceptive requirements of the protocol.

- Subject is able to swallow a capsule.

Exclusion Criteria:

- 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.

- Subject has a current co-morbid psychiatric disorder. Excluded are: any significant

Axis II disorder (including borderline personality disorder), any bipolar disorder, any current or lifetime psychosis, post traumatic stress disorder, obsessive compulsive disorder, any pervasive development disorder, anorexia nervosa and bulimia nervosa.

- 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 in the opinion of the Investigator, 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 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 had electroconvulsive therapy (ECT) for the current depressive episode 3

months prior.

- 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.

Locations and Contacts

ALPHA Recherche Clinique, Quebec G3K 2P8, Canada

Poliklinika Neuron, Zagreb 10 000, Croatia

Psychiatric Clinic Vrapoe, Zagreb 10090, Croatia

Hospital Aranda de la Parra, Leon Guanajuato 37000, Mexico

Instituto de Infromacion e Investigación en Salud Mental (INFOSAME), Nuevo Leon 64710, Mexico

Consultorio Especializado en Psiquiatria Infantil y Adolescentes, San Luis Potosi 78200, Mexico

B & B Investigaciones Medicas S.C., Sinaloa 82126, Mexico

Dharma Institute & Research Center, San Juan 00907, Puerto Rico

INSPIRA Clinical Research, San Juan 00918, Puerto Rico

Hospital de la Santa Creo l Sant Pau, Barcelona 08025, Spain

Hospital Universitari de Bellvitge, Servicio de Psiquiatria, Barcelona 08907, Spain

Hospital Fundacion de Alcorcon, Madrid 28922, Spain

Hospital Universitario de Henares, Madrid, Spain

Hospital Universitario Infanta Leonor, Madrid 28031, Spain

Centro de Salud Mental Il la Corredoria, Oviedo 33011, Spain

Centro Salud Alamedilla Unidad de Salud Mental, Salamanca 37003, Spain

Complejo hospitalario de Zamora, Zamora 49021, Spain

Hospital Clinico Universitario Lozano Blesa, Zaragoza 50009, Spain

Birmingham Research Group, Birmingham, Alabama 35216, United States

Dr. Alexander McIntyre Inc, Penticton, British Columbia V2A 4M4, Canada

Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc., Vancouver, British Columbia V6Z 2L4, Canada

AV Institue, Inc., Carson, California 90746, United States

University of California, Irvine Child Development Center, Irvine, California 92612, United States

South Coast Clinicals, Norwalk, California 90650, United States

North County Clinical Research, Oceanside, California 92056, United States

Pasadena Research Institute, LLC, Pasadena, California 91106, United States

Affiliated Research Institute, San Diego, California 92108, United States

Clinical Innovations, Inc., San Diego, California 92121, United States

Sharp Mesa Vista Hospital, San Diego, California 92123, United States

Geriatric and Adult Psychiatry, LLC, Hamden, Connecticut 06518, United States

Middlexex Hospital Center for Behavioral Health, Middletown, Connecticut 06457, United States

CNS Clinical Research Group, Coral Springs, Florida 33067, United States

Emerald Coast Mood & Memory, PA, Fort Walton Beach, Florida 32547, United States

Florida Clinical Research Center, LLC., Maitland, Florida 32751, United States

Suncoast Clinical Research, New Port Richey, Florida 34652, United States

Compass Research, LLC, Orlando, Florida 32806, United States

Meridien Research, St. Petersburg, Florida 33709, United States

Stedman Clinical Trials, Tampa, Florida 33613, United States

Carman Research, Smyrna, Georgia 30080, United States

American Medical Research, Inc., Oak Brook, Illinois 60523, United States

The Davis Clinic, Indianapolis, Indiana 46260, United States

Northwest Indiana Center for Clinical Research, Valparaiso, Indiana 46383, United States

MCM Clinical Research LLC, Florence, Kentucky 41042, United States

Pharmasite Research, Inc., Baltimore, Maryland 21208, United States

Potomac Grove Clinical Research Center, Gaithersburg, Maryland 20877, United States

Office of Marc Hertzman, MD, Rockville, Maryland 20852, United States

Adams Clinical Trials, LLC, Watertown, Massachusetts 02472, United States

St. Charles Psychiatric Associates - Midwest Research Group, St. Charles, Missouri 63301, United States

Bioscience Research, LLC, Mt. Kisco, New York 10549, United States

Fieve Clinical Research, New York, New York 10168, United States

Richmond Behavioral Associates, Staten Island, New York 10312, United States

Triangle Neuropsychiatry, Durham, North Carolina 27707, United States

Rcihard H. Weisler, MD, PA & Associates, Raleigh, North Carolina 27809, United States

Centro Regiomontano de Investigacion S.C. (CRI), Monterrey, Nuevo Leon 647-10, Mexico

Community Research, Cincinatti, Ohio 45227, United States

Lindner Center of HOPE, Mason, Ohio 45040, United States

SP Research, PLLC, Oklahoma City, Oklahoma 73112, United States

Aggarwal & Associates Ltd., Brampton, Ontario L6T 0G1, Canada

Depression, Mood Disorders and Schizophrenia Treatment Centre, Burlington, Ontario L7R 4E2, Canada

Chatham-Kent Clinical Trials Research Center, Chatham, Ontario N7M 5L9, Canada

Regional Mental Health Care, London, Ontario N6A 4H1, Canada

Anxiety and Mood Disorder Center, Mississauga, Ontario L5M 4N4, Canada

Medical Research Associates, Mississauga, Ontario L5M 4N4, Canada

A.K. Karan Holdings, Oakville, Ontario L6J0B2, Canada

International Sleep Clinic, West Parry Sound Health Centre, Parry Sound, Ontario P2A 3A4, Canada

Manna Research, Toronto, Ontario M9W 4L6, Canada

Sleep & Alertness Clinic (Sleep & Alertness Research, Inc.), Toronto, Ontario M6J 3S3, Canada

START Clinic for Mood and Anxiety Disorders, Toronto, Ontario M4W 2N4, Canada

Univ Health Network, Toronto Western Hospital, Toronto, Ontario M5T2S8, Canada

Windsor Regional Hospital-Tayfour Campus, Windsor, Ontario N9C 3Z4, Canada

Summit Research Network (Oregon) Inc., Portland, Oregon 97210, United States

Paramount Clinical Research, Bridgeville, Pennsylvania 15107, United States

Suburban Research Associates, Media, Pennsylvania 19063, United States

CRI Worldwide LLC, Philadelphia, Pennsylvania 19139, United States

University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania 15213, United States

Pierre-Janet Hospital, Gatineau, Quebec J8A1K7, Canada

l'Hopital Louis H. Lafontaine, Montreal, Quebec H1N 3M5, Canada

Kells Medical Research Group Inc., Pointe-Claire, Quebec H9R 4S3, Canada

Q&T Research Sherbrooke, Sherbrooke, Quebec J1H 4J6, Canada

Rhode Island Mood & Memory Research Institute, East Providence, Rhode Island 02914, United States

Clinical Neuroscience Solutions, Inc., Memphis, Tennessee 38119, United States

Clinical Research Associates, Nashville, Tennessee 37203, United States

FutureSearch Clinical Trials, LP, Austin, Texas 78731, United States

Ericksen Research and Development, Clinton, Utah 84015, United States

Summit Research Network (Seattle) LLC, Seattle, Washington 98104, United States

Additional Information

Starting date: October 2011
Last updated: April 13, 2015

Page last updated: August 23, 2015

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