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

NCT01436149 | Completed Phase 3 Results

• 2 other identifiers: SPD489-3222011-003018-17
• Study Type: interventional
• Target: 1,262
• Locations: 6 countries
• Sites: 85

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. 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?

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

  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.

  8 weeks

Secondary Outcomes (11)

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

  8 weeks

• Percentage of Participants Achieving a 25% Response on the MADRS

  up to 8 weeks

• Percentage of Participants Achieving a 50% Response on the MADRS

  up to 8 weeks

• Percentage of Participants Achieving Remission on the MADRS

  up to 8 weeks

• Mean Change From Baseline Over Time in MADRS Total Score

  Baseline and up to 8 weeks

Study Arms (2)

Antidepressant + SPD489

EXPERIMENTAL

Drug: SPD489 (Lisdexamfetamine dimesylate )

Antidepressant + Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SPD489 (Lisdexamfetamine dimesylate ) DRUG

Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks

Also known as: Vyvanse

Antidepressant + SPD489

Placebo DRUG

Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks

Antidepressant + Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shire: lead

Study Sites (85)

Birmingham Research Group

Birmingham, Alabama, 35216, United States

Location

AV Institue, Inc.

Carson, California, 90746, United States

Location

University of California, Irvine Child Development Center

Irvine, California, 92612, United States

Location

South Coast Clinicals

Norwalk, California, 90650, United States

Location

North County Clinical Research

Oceanside, California, 92056, United States

Location

Pasadena Research Institute, LLC

Pasadena, California, 91106, United States

Location

Affiliated Research Institute

San Diego, California, 92108, United States

Location

Clinical Innovations, Inc.

San Diego, California, 92121, United States

Location

Sharp Mesa Vista Hospital

San Diego, California, 92123, United States

Location

Geriatric and Adult Psychiatry, LLC

Hamden, Connecticut, 06518, United States

Location

Middlexex Hospital Center for Behavioral Health

Middletown, Connecticut, 06457, United States

Location

CNS Clinical Research Group

Coral Springs, Florida, 33067, United States

Location

Emerald Coast Mood & Memory, PA

Fort Walton Beach, Florida, 32547, United States

Location

Florida Clinical Research Center, LLC.

Maitland, Florida, 32751, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33613, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

American Medical Research, Inc.

Oak Brook, Illinois, 60523, United States

Location

The Davis Clinic

Indianapolis, Indiana, 46260, United States

Location

Northwest Indiana Center for Clinical Research

Valparaiso, Indiana, 46383, United States

Location

MCM Clinical Research LLC

Florence, Kentucky, 41042, United States

Location

Pharmasite Research, Inc.

Baltimore, Maryland, 21208, United States

Location

Potomac Grove Clinical Research Center

Gaithersburg, Maryland, 20877, United States

Location

Office of Marc Hertzman, MD

Rockville, Maryland, 20852, United States

Location

Adams Clinical Trials, LLC

Watertown, Massachusetts, 02472, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Fieve Clinical Research

New York, New York, 10168, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Triangle Neuropsychiatry

Durham, North Carolina, 27707, United States

Location

Rcihard H. Weisler, MD, PA & Associates

Raleigh, North Carolina, 27809, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

SP Research, PLLC

Oklahoma City, Oklahoma, 73112, United States

Location

Summit Research Network (Oregon) Inc.

Portland, Oregon, 97210, United States

Location

Paramount Clinical Research

Bridgeville, Pennsylvania, 15107, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

CRI Worldwide LLC

Philadelphia, Pennsylvania, 19139, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, 02914, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

FutureSearch Clinical Trials, LP

Austin, Texas, 78731, United States

Location

Ericksen Research and Development

Clinton, Utah, 84015, United States

Location

Summit Research Network (Seattle) LLC

Seattle, Washington, 98104, United States

Location

Dr. Alexander McIntyre Inc

Penticton, British Columbia, V2A 4M4, Canada

Location

Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.

Vancouver, British Columbia, V6Z 2L4, Canada

Location

Aggarwal & Associates Ltd.

Brampton, Ontario, L6T 0G1, Canada

Location

Depression, Mood Disorders and Schizophrenia Treatment Centre

Burlington, Ontario, L7R 4E2, Canada

Location

Chatham-Kent Clinical Trials Research Center

Chatham, Ontario, N7M 5L9, Canada

Location

Regional Mental Health Care

London, Ontario, N6A 4H1, Canada

Location

Anxiety and Mood Disorder Center

Mississauga, Ontario, L5M 4N4, Canada

Location

Medical Research Associates

Mississauga, Ontario, L5M 4N4, Canada

Location

A.K. Karan Holdings

Oakville, Ontario, L6J0B2, Canada

Location

International Sleep Clinic, West Parry Sound Health Centre

Parry Sound, Ontario, P2A 3A4, Canada

Location

START Clinic for Mood and Anxiety Disorders

Toronto, Ontario, M4W 2N4, Canada

Location

Univ Health Network, Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

Sleep & Alertness Clinic (Sleep & Alertness Research, Inc.)

Toronto, Ontario, M6J 3S3, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Windsor Regional Hospital-Tayfour Campus

Windsor, Ontario, N9C 3Z4, Canada

Location

Pierre-Janet Hospital

Gatineau, Quebec, J8A1K7, Canada

Location

l'Hopital Louis H. Lafontaine

Montreal, Quebec, H1N 3M5, Canada

Location

Kells Medical Research Group Inc.

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

ALPHA Recherche Clinique

Québec, Quebec, G3K 2P8, Canada

Location

Q&T Research Sherbrooke

Sherbrooke, Quebec, J1H 4J6, Canada

Location

Poliklinika Neuron

Zagreb, 10 000, Croatia

Location

Psychiatric Clinic Vrapoe

Zagreb, 10090, Croatia

Location

Centro Regiomontano de Investigacion S.C. (CRI)

Monterrey, Nuevo León, 647-10, Mexico

Location

Hospital Aranda de la Parra

León, 37000, Mexico

Location

Instituto de Infromacion e Investigación en Salud Mental (INFOSAME)

Nuevo León, 64710, Mexico

Location

Consultorio Especializado en Psiquiatria Infantil y Adolescentes

San Luis Potosí City, 78200, Mexico

Location

B & B Investigaciones Medicas S.C.

Sinaloa, 82126, Mexico

Location

Dharma Institute & Research Center

San Juan, 00907, Puerto Rico

Location

INSPIRA Clinical Research

San Juan, 00918, Puerto Rico

Location

Hospital de la Santa Creo l Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari de Bellvitge, Servicio de Psiquiatria

Barcelona, 08907, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Fundacion de Alcorcon

Madrid, 28922, Spain

Location

Hospital Universitario de Henares

Madrid, Spain

Location

Centro de Salud Mental Il la Corredoria

Oviedo, 33011, Spain

Location

Centro Salud Alamedilla Unidad de Salud Mental

Salamanca, 37003, Spain

Location

Complejo hospitalario de Zamora

Zamora, 49021, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Richards C, McIntyre RS, Weisler R, Sambunaris A, Brawman-Mintzer O, Gao J, Geibel B, Dauphin M, Madhoo M. Lisdexamfetamine dimesylate augmentation for adults with major depressive disorder and inadequate response to antidepressant monotherapy: Results from 2 phase 3, multicenter, randomized, double-blind, placebo-controlled studies. J Affect Disord. 2016 Dec;206:151-160. doi: 10.1016/j.jad.2016.07.006. Epub 2016 Jul 5.

  PMID: 27474961 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: October 27, 2011
• Primary Completion: December 23, 2013
• Study Completion: December 23, 2013
• Last Updated: June 9, 2021
• Results First Posted: November 19, 2014

Record last verified: 2021-05

Locations

CA (20); CR (2); PR (2); US (47); ME (5); ES (9)