Clinical trial NCT01072630: Study to Evaluate the Efficacy and Safety of Armodafinil Treatment as Adjunctive Therapy in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Bipolar I Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 492
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Day 0 (baseline), Week 8
Secondary outcomes:
measure: Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score
timeFrame: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale
timeFrame: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)
measure: Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: Day 1 to Week 9
measure: Change From Baseline to Endpoint in the Young Mania Rating Scale Total Score
timeFrame: Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
measure: Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score
timeFrame: Day 0 (baseline), Week 8 or last postbaseline observation (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
measure: 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
timeFrame: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc
state: Alabama
city: Anaheim
country: United States
facility: South Coast Medical Associates/SC Clinical Trials, Inc.
state: California
city: Cerritos
country: United States
facility: Comprehensive NeuroScience
state: California
city: Imperial
country: United States
facility: Sun Valley Behavioral Medical
state: California
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: Pico Rivera
country: United States
facility: CNRI Los Angeles LLC
state: California
city: San Diego
country: United States
facility: CNRI-San Diego LLC
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations Inc.
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Center
state: California
city: Washington DC
country: United States
facility: Comprehensive NeuroScience
state: District of Columbia
city: Aventura
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Bradenton
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Clinical Research Center
state: Hawaii
city: Oakbrook Terrace
country: United States
facility: Midwest Center for Neurobehavioral Medicine
state: Illinois
city: Park Ridge
country: United States
facility: CNS - Comprehensive Neuro Science
state: Illinois
city: Crestview Hills
country: United States
facility: Community Research
state: Kentucky
city: Fall River
country: United States
facility: AccelRx Research
state: Massachusetts
city: Rochester
country: United States
facility: Mayo College of Medicine
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Mount Laurel
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: Behavioral Medical Research of Brooklyn
state: New York
city: New York
country: United States
facility: Fieve Clinical Services, Inc.
state: New York
city: New York
country: United States
facility: Medical and Behavioral Health Research
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Beachwood
country: United States
facility: North Coast Clinical Trials, Inc.
state: Ohio
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center for Clinical Investigators, Inc. (OCCI, Inc.)
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center for Comprehensive Treatment
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Desoto
country: United States
facility: Insite Clinical Research
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, P.A.
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: Clinical Methods
state: Utah
city: Richmond
country: United States
facility: Alliance Research Group
state: Virginia
city: Buenos Aires
country: Argentina
facility: B.A. Psychiatric Research Cent
city: Buenos Aires
country: Argentina
facility: Dr. Gregorio Hugo Sorin
city: Buenos Aires
country: Argentina
facility: INECO
city: Buenos Aires
country: Argentina
facility: Instituto FLENI
city: Córdoba
country: Argentina
facility: Sanatorio Prof. León S. Morra SA
city: Rosario
country: Argentina
facility: Centro de Investigación y asistencia en Psiquiatria (CIAP)
city: Malvern
country: Australia
facility: Neurotherapy Victoria Clinical Trials
state: Victoria
city: Melbourne
country: Australia
facility: Northern Area Mental Health Services Northern Psychiatric R
state: Victoria
city: Bourgas
country: Bulgaria
facility: District Department of Psychiatric Disorders With Stationary
city: Pazardjik
country: Bulgaria
facility: State Psychiatric Hospital - Pazardjik
city: Pleven
country: Bulgaria
facility: Psychiatric clinic for women UMHAT "Dr. Georgi Stranski"
city: Plovdiv
country: Bulgaria
facility: ODPZS- EOOD, Plovdiv, Bulgaria
city: Sofia
country: Bulgaria
facility: MHAT Doverie
city: Sofia
country: Bulgaria
facility: Psychiatric clinic, University Hospital "Alexandrovska"
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Center "Tchaika"
city: Varna
country: Bulgaria
facility: MHAT - Sveta Marina
city: Edmonton
country: Canada
facility: Grey Nuns Hospital
state: Alberta
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre, Inc.
state: British Columbia
city: Kingston
country: Canada
facility: Providence Care Mental Health Services
state: Ontario
city: Mississauga
country: Canada
facility: Medical Research Associates
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Louis Hlafontaine
state: Quebec
city: Dole
country: France
facility: CMP/CHS du Jura
city: Jonzac
country: France
facility: Centre Hospitalier de Jonzac
city: Nîmes
country: France
facility: Hopital Universitaire Caremeau-Batiment Polyvalent, Service
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy
city: Gdansk
country: Poland
facility: Klinika Chorob Psychicznych i Zaburzen Nerwicowych GUM
city: Gdansk
country: Poland
facility: Wojewodzki Szpital Psychiatryczny im. prof. Tadeusza Bilikie
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Cape Town
country: South Africa
facility: Cape Trial Centre
city: Cape Town
country: South Africa
facility: Flexivest Fourteen Research Centre
city: Cape Town
country: South Africa
facility: Knighton Surgery
city: Centurion
country: South Africa
facility: Vista Clinic
city: Johannesburg
country: South Africa
facility: Dr Magnus & Dr Brink
city: Paarl
country: South Africa
facility: Paarl Medical Centre
city: Pretoria
country: South Africa
facility: Dey Clinic
city: Coslada (Madrid)
country: Spain
facility: Hospital del Henares
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Psiquiátrico de Álava
city: Vitoria
country: Spain
facility: Hospital Santiago Apostol
city: s. Oleksandrivka
country: Ukraine
facility: Odessa Regional Mental Hospital #2
state: Odessa
city: Donetsk
country: Ukraine
facility: Donetsk National Medical University n.a. M. Horkyy
city: Kharkiv
country: Ukraine
facility: Public Institution "Institute of Neurology, Psychiatry and N
city: Kiev
country: Ukraine
facility: Kiev City Psychoneurological Hospital N 1, CNTRP
city: Lviv
country: Ukraine
facility: Danylo Galitsky Lviv State Medical University
city: Odessa
country: Ukraine
facility: Odessa Regional Psychoneurology Dispensary
city: Vinnitsa
country: Ukraine
facility: Vinnytsa National Medical University named by M.I. Pirogov
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
citation: Ketter TA, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder. J Affect Disord. 2015 Aug 1;181:87-91. doi: 10.1016/j.jad.2015.04.012. Epub 2015 Apr 15.