Clinical trial NCT01072929: A 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: 433
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 4, 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 (YMRS) Total Score
timeFrame: Day 0 (baseline), 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), 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), 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 Research Group
state: Alabama
city: Beverly Hills
country: United States
facility: Southwestern Research
state: California
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Network
state: California
city: Imperial
country: United States
facility: Sun Valley Behavioral Medical
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations Inc.
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Center
state: California
city: Coral Springs
country: United States
facility: CNS Clinical Research Group - Florida Clinical Research Cent
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Jacksonville
country: United States
facility: Dr. Vijapura and Assoc.
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Comprehensive Neuroscience, Inc
state: Georgia
city: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Naperville
country: United States
facility: AMR Baber Research Inc.
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research
state: Illinois
city: Park Ridge
country: United States
facility: CNS - Comprehensive Neuro Science
state: Illinois
city: Baltimore
country: United States
facility: Pharmasite Research, Inc
state: Maryland
city: Fall River
country: United States
facility: AccelRx Research
state: Massachusetts
city: St. Louis
country: United States
facility: Mid-America Clinical Research, LLC
state: Missouri
city: Mount Laurel
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Albequerque Neuroscience
state: New Mexico
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Raleigh
country: United States
facility: Richard Weisler, MD and Associates
state: North Carolina
city: Beachwood
country: United States
facility: Charak Clinical Research Center
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Scranton
country: United States
facility: Scranton Counseling Center
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Cephalon
name: Sponsor's Medical Expert
role: STUDY_DIRECTOR
References:
citation: Calabrese JR, Frye MA, Yang R, Ketter TA; Armodafinil Treatment Trial Study Network. Efficacy and safety of adjunctive armodafinil in adults with major depressive episodes associated with bipolar I disorder: a randomized, double-blind, placebo-controlled, multicenter trial. J Clin Psychiatry. 2014 Oct;75(10):1054-61. doi: 10.4088/JCP.13m08951.