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.
Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total ScorePercentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
Participants With Treatment-Emergent Adverse Events (TEAE)
Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score
Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question
Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Inclusion Criteria:
- The patient has a diagnosis of bipolar I disorder according to Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (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, electrocardiography (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.
B.A. Psychiatric Research Cent, Buenos Aires, Argentina
Dr. Gregorio Hugo Sorin, Buenos Aires, Argentina
INECO, Buenos Aires, Argentina
Instituto FLENI, Buenos Aires, Argentina
Sanatorio Prof. León S. Morra SA, Córdoba, Argentina
Centro de Investigación y asistencia en Psiquiatria (CIAP), Rosario, Argentina
District Department of Psychiatric Disorders With Stationary, Bourgas, Bulgaria
State Psychiatric Hospital - Pazardjik, Pazardjik, Bulgaria
Psychiatric clinic for women UMHAT "Dr. Georgi Stranski", Pleven, Bulgaria
ODPZS- EOOD, Plovdiv, Bulgaria, Plovdiv, Bulgaria
MHAT Doverie, Sofia, Bulgaria
Psychiatric clinic, University Hospital "Alexandrovska", Sofia, Bulgaria
Diagnostic Consultative Center "Tchaika", Varna, Bulgaria
MHAT - Sveta Marina, Varna, Bulgaria
CMP/CHS du Jura, Dole, France
Centre Hospitalier de Jonzac, Jonzac, France
Hopital Universitaire Caremeau-Batiment Polyvalent, Service, Nîmes, France
Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy, Bydgoszcz, Poland
Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM, Gdansk, Poland
Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie, Gdansk, Poland
Malopolskie Centrum Medyczne, Krakow, Poland
Cape Trial Centre, Cape Town, South Africa
Flexivest Fourteen Research Centre, Cape Town, South Africa
Knighton Surgery, Cape Town, South Africa
Vista Clinic, Centurion, South Africa
Dr Magnus & Dr Brink, Johannesburg, South Africa
Paarl Medical Centre, Paarl, South Africa
Dey Clinic, Pretoria, South Africa
Hospital del Henares, Coslada (Madrid), Spain
Clínica Universitaria de Navarra, Pamplona, Spain
Hospital Psiquiátrico de Álava, Vitoria-Gasteiz, Spain
Hospital Santiago Apostol, Vitoria, Spain
Donetsk National Medical University n.a. M. Horkyy, Donetsk, Ukraine
Public Institution "Institute of Neurology, Psychiatry and N, Kharkiv, Ukraine
Kiev City Psychoneurological Hospital N 1, CNTRP, Kiev, Ukraine
Danylo Galitsky Lviv State Medical University, Lviv, Ukraine
Odessa Regional Psychoneurology Dispensary, Odessa, Ukraine
Vinnytsa National Medical University named by M.I. Pirogov, Vinnitsa, Ukraine
Birmingham Psychiatry Pharmaceutical Studies, Inc, Birmingham, Alabama, United States
Grey Nuns Hospital, Edmonton, Alberta, Canada
Dr. Alexander McIntyre, Inc., Penticton, British Columbia, Canada
South Coast Medical Associates/SC Clinical Trials, Inc., Anaheim, California, United States
Comprehensive NeuroScience, Cerritos, California, United States
Sun Valley Behavioral Medical, Imperial, California, United States
North County Clinical Research, Oceanside, California, United States
CNRI Los Angeles LLC, Pico Rivera, California, United States
CNRI-San Diego LLC, San Diego, California, United States
Clinical Innovations Inc., Santa Ana, California, United States
Schuster Medical Research Institute, Sherman Oaks, California, United States
Stanford University Medical Center, Stanford, California, United States
Viking Clinical Research Center, Temecula, California, United States
Comprehensive NeuroScience, Washington DC, District of Columbia, United States
Scientific Clinical Research, Inc., Aventura, Florida, United States
Florida Clinical Research Center, Bradenton, Florida, United States
Clinical Neuroscience Solutions Inc, Jacksonville, Florida, United States
Fidelity Clinical Research, Lauderhill, Florida, United States
Compass Research, LLC, Orlando, Florida, United States
Stedman Clinical Trials, LLC, Tampa, Florida, United States
Atlanta Center for Medical Research, Atlanta, Georgia, United States
Carman Research, Smyrna, Georgia, United States
Hawaii Clinical Research Center, Honolulu, Hawaii, United States
Midwest Center for Neurobehavioral Medicine, Oakbrook Terrace, Illinois, United States
CNS - Comprehensive Neuro Science, Park Ridge, Illinois, United States
Community Research, Crestview Hills, Kentucky, United States
AccelRx Research, Fall River, Massachusetts, United States
Mayo College of Medicine, Rochester, Minnesota, United States
Precise Research Centers, Flowood, Mississippi, United States
CRI Worldwide, LLC, Mount Laurel, New Jersey, United States
Behavioral Medical Research of Brooklyn, Brooklyn, New York, United States
Fieve Clinical Services, Inc., New York, New York, United States
Medical and Behavioral Health Research, New York, New York, United States
Behavioral Medical Research of Staten Island, Staten Island, New York, United States
Richmond Behavioral Associates, Staten Island, New York, United States
Odessa Regional Mental Hospital #2, s. Oleksandrivka, Odessa, Ukraine
North Coast Clinical Trials, Inc., Beachwood, Ohio, United States
Neuro-Behavioral Clinical Research, Inc, Canton, Ohio, United States
IPS Research Company, Oklahoma City, Oklahoma, United States
Providence Care Mental Health Services, Kingston, Ontario, Canada
Medical Research Associates, Mississauga, Ontario, Canada
Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.), Portland, Oregon, United States
Lehigh Center for Clinical Research, Allentown, Pennsylvania, United States
Belmont Center for Comprehensive Treatment, Philadelphia, Pennsylvania, United States
Hôpital Louis Hlafontaine, Montreal, Quebec, Canada
FutureSearch Trials of Neurology, Austin, Texas, United States
Insite Clinical Research, Desoto, Texas, United States
Red Oak Psychiatry Associates, P.A., Houston, Texas, United States
University Hills Clinical Research, Irving, Texas, United States
Aspen Clinical Research, LLC, Orem, Utah, United States
Clinical Methods, Salt Lake City, Utah, United States
Neurotherapy Victoria Clinical Trials, Malvern, Victoria, Australia
Northern Area Mental Health Services Northern Psychiatric R, Melbourne, Victoria, Australia
Alliance Research Group, Richmond, Virginia, United States