Clinical trial NCT01436149: Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 1262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Participants Achieving a 25% Response on the MADRS
timeFrame: up to 8 weeks
measure: Percentage of Participants Achieving a 50% Response on the MADRS
timeFrame: up to 8 weeks
measure: Percentage of Participants Achieving Remission on the MADRS
timeFrame: up to 8 weeks
measure: Mean Change From Baseline Over Time in MADRS Total Score
timeFrame: Baseline and up to 8 weeks
measure: Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)
timeFrame: up to 8 weeks
measure: Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)
timeFrame: up to 8 weeks
measure: Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
timeFrame: up to 8 weeks
measure: Clinical Global Impressions - Global Improvement (CGI-I)
timeFrame: up to 8 weeks
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: up to 8 weeks
measure: Amphetamine Cessation Symptom Assessment (ACSA)
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Carson
country: United States
facility: AV Institue, Inc.
state: California
city: Irvine
country: United States
facility: University of California, Irvine Child Development Center
state: California
city: Norwalk
country: United States
facility: South Coast Clinicals
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute, LLC
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: Clinical Innovations, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Hamden
country: United States
facility: Geriatric and Adult Psychiatry, LLC
state: Connecticut
city: Middletown
country: United States
facility: Middlexex Hospital Center for Behavioral Health
state: Connecticut
city: Coral Springs
country: United States
facility: CNS Clinical Research Group
state: Florida
city: Fort Walton Beach
country: United States
facility: Emerald Coast Mood & Memory, PA
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Indianapolis
country: United States
facility: The Davis Clinic
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Florence
country: United States
facility: MCM Clinical Research LLC
state: Kentucky
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Gaithersburg
country: United States
facility: Potomac Grove Clinical Research Center
state: Maryland
city: Rockville
country: United States
facility: Office of Marc Hertzman, MD
state: Maryland
city: Watertown
country: United States
facility: Adams Clinical Trials, LLC
state: Massachusetts
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: New York
country: United States
facility: Fieve Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Durham
country: United States
facility: Triangle Neuropsychiatry
state: North Carolina
city: Raleigh
country: United States
facility: Rcihard H. Weisler, MD, PA & Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Mason
country: United States
facility: Lindner Center of HOPE
state: Ohio
city: Oklahoma City
country: United States
facility: SP Research, PLLC
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre Inc
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. D. McIntosh & Dr. K. Kjernisted Clinical Research Inc.
state: British Columbia
city: Brampton
country: Canada
facility: Aggarwal & Associates Ltd.
state: Ontario
city: Burlington
country: Canada
facility: Depression, Mood Disorders and Schizophrenia Treatment Centre
state: Ontario
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials Research Center
state: Ontario
city: London
country: Canada
facility: Regional Mental Health Care
state: Ontario
city: Mississauga
country: Canada
facility: Anxiety and Mood Disorder Center
state: Ontario
city: Mississauga
country: Canada
facility: Medical Research Associates
state: Ontario
city: Oakville
country: Canada
facility: A.K. Karan Holdings
state: Ontario
city: Parry Sound
country: Canada
facility: International Sleep Clinic, West Parry Sound Health Centre
state: Ontario
city: Toronto
country: Canada
facility: START Clinic for Mood and Anxiety Disorders
state: Ontario
city: Toronto
country: Canada
facility: Univ Health Network, Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sleep & Alertness Clinic (Sleep & Alertness Research, Inc.)
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital-Tayfour Campus
state: Ontario
city: Gatineau
country: Canada
facility: Pierre-Janet Hospital
state: Quebec
city: Montreal
country: Canada
facility: l'Hopital Louis H. Lafontaine
state: Quebec
city: Pointe-Claire
country: Canada
facility: Kells Medical Research Group Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: ALPHA Recherche Clinique
city: Zagreb
country: Croatia
facility: Poliklinika Neuron
city: Zagreb
country: Croatia
facility: Psychiatric Clinic Vrapoe
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Investigacion S.C. (CRI)
state: Nuevo Leon
city: Leon Guanajuato
country: Mexico
facility: Hospital Aranda de la Parra
city: Nuevo Leon
country: Mexico
facility: Instituto de Infromacion e Investigación en Salud Mental (INFOSAME)
city: San Luis Potosi
country: Mexico
facility: Consultorio Especializado en Psiquiatria Infantil y Adolescentes
city: Sinaloa
country: Mexico
facility: B & B Investigaciones Medicas S.C.
city: San Juan
country: Puerto Rico
facility: Dharma Institute & Research Center
city: San Juan
country: Puerto Rico
facility: INSPIRA Clinical Research
city: Barcelona
country: Spain
facility: Hospital de la Santa Creo l Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge, Servicio de Psiquiatria
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Fundacion de Alcorcon
city: Madrid
country: Spain
facility: Hospital Universitario de Henares
city: Oviedo
country: Spain
facility: Centro de Salud Mental Il la Corredoria
city: Salamanca
country: Spain
facility: Centro Salud Alamedilla Unidad de Salud Mental
city: Zamora
country: Spain
facility: Complejo hospitalario de Zamora
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.