A Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Condition(s) targeted: Depression

Intervention: Armodafinil (Drug); Armodafinil (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cephalon

Official(s) and/or principal investigator(s):
Sponsor's Medical Expert, Study Director, Affiliation: Cephalon

Overall contact:
Cephalon Contact, Phone: 1-877-237-4879

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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: 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

Secondary outcome:

Clinical Global Impression of Severity (CGI-S) of depression rating

Global Assessment of Functioning (GAF) Scale scores

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

Criteria:

Inclusion Criteria:

- The patient has a diagnosis of bipolar I disorder according to DSM-IV-TR criteria and

is currently experiencing a major depressive episode.

- Documentation that the patient has had at least 1 previous manic or mixed episode.

- The patient has had no more than 6 mood episodes in the last year.

- The patient's current major depressive episode must have started no less than 2 weeks

and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.

- The patient must have been taking 1 (or 2) of the following protocol-allowed mood

stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid).

- Written informed consent is obtained.

- The patient is a man or woman 18 through 65 years of age.

- The patient is in good health (except for diagnosis of bipolar I disorder) as judged

by the investigator, on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis.

- Women of childbearing potential (women who have not reached menopause, women who are

less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.

- The patient is willing and able to comply with study restrictions and to attend

regularly scheduled clinic visits as specified in this protocol.

- The patient has permanent accommodations and means of being contacted by the study

center.

- The patient understands that they may enroll in this clinical study only once and may

not enroll in any other clinical study while participating in this trial.

Exclusion Criteria:

- The patient has any Axis I disorder apart from bipolar I disorder that was the

primary focus of treatment within 6 months of the screening visit or during the screening period.

- The patient has psychotic symptoms or has had psychosis within 4 weeks of the

screening visit or during the screening period.

- The patient has current active suicidal ideation, is at imminent risk of self-harm,

or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.

- The patient has a history of an eating disorder or obsessive compulsive disorder

(OCD) within 6 months of the screening visit or during the screening period.

- The patient has a history of alcohol or substance abuse or dependence (with the

exception of nicotine dependence) within 3 months of the screening visit or during the screening period.

- The patient has a history of any cutaneous drug reaction or drug hypersensitivity

reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies.

- The patient has any clinically significant uncontrolled medical condition, treated or

untreated.

- The patient has received modafinil or armodafinil within the past 5 years, or the

patient has a known sensitivity to any ingredients in the study drug tablets.

- The patient has previously participated in a clinical study with armodafinil or has

used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study.

- The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain

stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit.

- The patient is a pregnant or lactating woman.

Cephalon Contact, Phone: 1-877-237-4879

Fundación para el Tratamiento y el estudios de las enfermedades mentales, Buenos Aires C1425AHQ, Argentina; Recruiting
Central Contact

Instituto Medico CER, Buenos Aires, Argentina; Recruiting
Central Contact

Instituto Nacional de Psicopatología (INAPSI), Ciudad autónoma de Buenos Aires C1405BOA, Argentina; Recruiting
Central Contact

Asociación Neuropsiquiátrica Argentina (INEAR), Ciudad autónoma de Buenos Aires C1427EIB, Argentina; Recruiting
Central Contact

Clinica Privada Integral de Psiquiatria "San Nicolas" SRL, Córdoba 5004ALB, Argentina; Recruiting
Central Contact

Clinica Privada Neuropsiquiatrica San Agustin, La Plata 1900, Argentina; Recruiting
Central Contact

SPsyH Kardzhali, Kardzhali 6600, Bulgaria; Recruiting
Central Contact

MHAT Dr. Hristo Stambolski, Kazanlak 6100, Bulgaria; Recruiting
Central Contact

MHAT Sveti Georgi Plovdiv, Plovdiv 4002, Bulgaria; Recruiting
Central Contact

DistDisPsyDIU Ruse, Ruse 7003, Bulgaria; Recruiting
Central Contact

SHATNPsy Sveti Naum, Sofia 1113, Bulgaria; Recruiting
Central Contact

CH de l'Espan, Brumath, France; Recruiting
Central Contact

CHS la Chartreuse, Dijon 21033, France; Recruiting
Central Contact

Clinique Villa Bleue, Jarnac, France; Recruiting
Central Contact

CMPI, Le Vesinet 78110, France; Not yet recruiting
Central Contact

Hopital Universitaire Caremeau-Batiment Polyvalent, Service de Psychiatrie Adulte, Nîmes 30029, France; Recruiting
Central Contact

Gabinet Lekarski Psychiatycsny, Belchatow 97-400, Poland; Recruiting
Central Contact

Poradnia Zdrowia Psychicznego, Chelmno 86-200, Poland; Recruiting
Central Contact

Klinika Psychiatryczna Inventiva, Tuszyn 95-080, Poland; Recruiting
Central Contact

NZOZ Syntonia Poradnia Zdrowia Psychicznego, Warszawa 25-317, Poland; Recruiting
Central Contact

University Emergency Central Military Hospital, Bucharest, Romania; Recruiting
Central Contact

Clinical Hospital of Psychiatry Prof.Dr.Alexandru Obregia, Bucharest, Romania; Recruiting
Central Contact

Spitalul Clinic de Psihiatrie, Bucuresti, Romania; Recruiting
Central Contact

Spitalul Judetean Arges, Clinica de Psihiatrie, Pitesti 110069, Romania; Recruiting
Central Contact

SC Lorentina 2102 SRL, Targoviste, Romania; Recruiting
Central Contact

Institute for Psychiatry, Clinical Centre of Serbia, Belgrade 11000, Serbia; Recruiting
Central Contact

Clinical Center Dr Dragisa Misovic, Belgrade 11000, Serbia; Recruiting
Central Contact

Clinic for Psychiatry Military Medical Academy, Belgrade 11000, Serbia; Not yet recruiting
Central Contact

Institute of Mental Health, Belgrade 11000, Serbia; Not yet recruiting
Central Contact

Institute of Neuropsychiatry "Dr Laza Lazarevic", Belgrade 11000, Serbia; Not yet recruiting
Central Contact

PsychDptClin HospCentre Zvezdara, Belgrade 11 000, Serbia; Not yet recruiting
Central Contact

Clinical Centre Kragujevac, Kragujevac 34000, Serbia; Recruiting
Central Contact

Specialized Hospital for psychiatric diseases- Sveti vracevi, Novi Knezevac 23330, Serbia; Not yet recruiting
Central Contact

Hospital Verge dels Lliris de Alcoy, Alcoy 03804, Spain; Recruiting
Central Contact

Hospital Clinic de Barcelona, Barcelona 08036, Spain; Recruiting
Central Contact

Hospital Infanta Leonor, Madrid 28032, Spain; Recruiting
Central Contact

Hospital Universitario La Paz, Madrid 28035, Spain; Recruiting
Central Contact

Hospital Psiquiatrico Dr Rodriguez Lafora, Madrid 28049, Spain; Not yet recruiting
Central Contact

Hospital San Telmo, Palencia 34004, Spain; Recruiting
Central Contact

Hospital Clinico Universitario de Valladolid, Valladolid 47003, Spain; Recruiting
Central Contact

Regional Center of Psychosomatic Pathology of Dnipropetrovsk Regional Clinical Hospital named after Mechnikov, Dnipropetrovsk 49005, Ukraine; Recruiting
Central Contact

Lugansk State Medical University, Department of Psychiatry, Narcology and Medical Psychology. Lugansk Regional Clinical Psyconevrological Hospital, Lugansk 91045, Ukraine; Recruiting
Central Contact

Ukrainian Medical Stomatological Academy, Poltava 36006, Ukraine; Recruiting
Central Contact

Crimean State Medical University, Simferopol 95006, Ukraine; Recruiting
Central Contact

M.I. Pirogov Vinnitsa National Medical University, Vinnytsya 21018, Ukraine; Recruiting
Central Contact

Birmingham Research Group, Birmingham,, Alabama 35216, United States; Recruiting
Site Contact

Okanagan Clinical Trials, Kelowna, British Columbia V1Y 1Z9, Canada; Recruiting
Central Contact

Clinical Innovations, Inc., Costa Mesa, California 92626, United States; Recruiting
Central Contact

Collaborative NeuroScience Network, Garden Grove, California 92845, United States; Recruiting
Site Contact

Sun Valley Behavioral Medical, Imperial, California 92251, United States; Recruiting
Site Contact

Excell Research, Oceanside, California 92056, United States; Recruiting
Central Contact

University of California, Irvine, Orange, California 92868, United States; Recruiting
Central Contact

Artemis Institute for Clinical Research, San Diego, California 92123, United States; Recruiting
Site Contact

Viking Clinical Research Center, Temecula, California 92591, United States; Recruiting
Site Contact

Universitaires de Strasbourg Hopitaux, Strasbourg, Cedex 67091, France; Not yet recruiting
Central Contact

CNS Clinical Research Group - Florida Clinical Research Center, Coral Springs, Florida 33067, United States; Recruiting
Central Contact

Gulfcoast Clinical Research Center, Fort Myers, Florida 33912, United States; Recruiting
Central Contact

Sarkis Clinical Trials, Gainesville, Florida 32607, United States; Recruiting
Central Contact

Dr. Vijapura and Assoc., Jacksonville, Florida 32256, United States; Recruiting
Central Contact

Fidelity Clinical Research Behavioral Clinical Research, Lauderhill, Florida 33319, United States; Recruiting
Site Contact

Clinical Neuroscience Solutions Inc, Orlando, Florida 32806, United States; Recruiting
Site Contact

University of South Florida, Tampa, Florida 33613, United States; Recruiting
Site Contact

Comprehensive Neuroscience, Atlanta, Georgia 30328, United States; Recruiting
Site Contact

Northwest Behavioral Research Center, Marietta, Georgia 30060, United States; Recruiting
Site Contact

American Medical Research, Naperville, Illinois 60563, United States; Recruiting
Central Contact

AMR Baber Research, Inc., Naperville, Illinois 60563, United States; Recruiting
Central Contact

American Medical Research, Oak Brook, Illinois 60523, United States; Recruiting
Site Contact

Centro Integral de Diagnostico y Tratamiento Francisco Diaz, Alcala de Henares, Madrid 28806, Spain; Not yet recruiting
Central Contact

Pharmasite Research, Inc, Baltimore, Maryland 21208, United States; Recruiting
Central Contact

Mid-America Clinical Research, LLC, St. Louis, Missouri 63139, United States; Recruiting
Central Contact

Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia 30120, Spain; Not yet recruiting
Central Contact

Albequerque Neuroscience, Albuquerque, New Mexico 87109, United States; Recruiting
Central Contact

Social Psychiatry Research Institute, Brooklyn, New York 11235, United States; Recruiting
Site Contact

CNS, Fresh Meadows, New York 11366, United States; Recruiting
Central Contact

Eastside Comprehensive Medical Center, New York, New York 10021, United States; Recruiting
Site Contact

Finger Lakes Clinical Research, Rochester, New York 14618, United States; Recruiting
Site Contact

Richmond Behavioral Associates, Staten Island, New York 10312, United States; Recruiting
Site Contact

Richard Weisler, MD and Associates, Raleigh, North Carolina 27609, United States; Recruiting
Site Contact

Capital District Health Authority - Queen Elizabeth II, Halifax, Nova Scotia B3H 2E2, Canada; Recruiting
Central Contact

Mood Disorders Program at University Hospitals of Cleveland, Cleveland, Ohio 44106, United States; Recruiting
Central Contact

Midwest Clinical Research Center, Dayton, Ohio 45408, United States; Recruiting
Site Contact

Charak Clinical Research Center, Garfield Heights, Ohio 44125, United States; Recruiting
Central Contact

Chatham-Kent Health Alliance, Mental Health and Addictions, Chatham, Ontario N7L 1 B7, Canada; Recruiting
Central Contact

Anxiety and Mood Center, Mississauga, Ontario, Canada; Recruiting
Central Contact

Centre for Addiction and Mental Health, Toronto, Ontario M5T 1R8, Canada; Recruiting
Central Contact

Suburban Research Associates, Media, Pennsylvania 19063, United States; Recruiting
Site Contact

CRI Worldwide, Philadelphia, Pennsylvania 19139, United States; Recruiting
Site Contact

Scranton Counseling Center, Scranton, Pennsylvania 18503, United States; Recruiting
Site Contact

Hopital du Sacre-Coeur de Montreal-Clinique des maladies Affectives, Montreal, Quebec H3M 3A9, Canada; Recruiting
Central Contact

Dr Tom George Medical Trials Pty Ltd, Brisbane, Queensland 4053, Australia; Recruiting
Central Contact

AccelRx Research Lincoln Research, Lincoln, Rhode Island 02865, United States; Not yet recruiting
Site Contact

Carolina Clinical Trials, Inc, Charleston, South Carolina 29407, United States; Recruiting
Site Contact

Community Clinical Research, Austin, Texas 78754, United States; Recruiting
Site Contact

FutureSearch Trials of Neurology, Dallas, Texas 75231, United States; Recruiting
Site Contact

Austin Hospital, Heidelberg, Victoria 3084, Australia; Recruiting
Central Contact

Northwest Clinical Research Center, Bellevue, Washington 98007, United States; Recruiting
Site Contact

Starting date: February 2010
Last updated: September 13, 2011