Clinical trial NCT00481195: Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Official title: An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar I Depression
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-01
Enrollment: 257
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 if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.


Eligibility criteria: Key Inclusion Criteria:

* The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
* The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.

Key Exclusion Criteria:

* The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
* The patient has any clinically significant uncontrolled medical or surgical condition.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
* The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)

Primary outcomes:
measure: The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
timeFrame: Baseline and 8 weeks from start of study drug administration (or last observation after baseline)
Secondary outcomes:
measure: The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
timeFrame: Baseline and 1 week following the start of study drug administration
measure: The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
timeFrame: Baseline and 3 weeks following the start of study drug administration
measure: The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
timeFrame: Baseline and 6 weeks following the start of study drug administration
measure: The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
timeFrame: Baseline and 8 weeks following the start of study drug administration
measure: Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
measure: Number of Patients Achieving "Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
measure: Number of Patients Achieving "Sustained Remission" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
measure: Number of Patients Achieving "Sustained Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
timeFrame: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)
measure: Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
timeFrame: Baseline and 8 weeks (or last observation after baseline)
measure: Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3
timeFrame: Baseline and 8 weeks following the start of study drug administration
measure: Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
timeFrame: Baseline and 8 weeks (or last observation after baseline)
measure: Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4
timeFrame: Baseline and 8 weeks following the start of study drug administration
measure: Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)
measure: Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and 8 weeks following the start of study drug administration
measure: Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
timeFrame: Baseline and 8 weeks (or last observation after baseline)
measure: Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
timeFrame: Baseline and 1 week following the start of study drug administration
measure: Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
timeFrame: Baseline and 3 weeks following the start of study drug administration
measure: Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
timeFrame: Baseline and 6 weeks following the start of study drug administration
measure: Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)
timeFrame: Baseline and 8 weeks following the start of study drug administration
measure: Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
timeFrame: Baseline and 8 weeks (or last observation after baseline)
measure: Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
timeFrame: Baseline and 8 weeks following the start of study drug administration
measure: Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score
timeFrame: baseline and 8 weeks (or last observation after baseline)
measure: Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score
timeFrame: Baseline and 8 weeks following the start of study drug administration
measure: The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)
timeFrame: Baseline and 8 weeks (or last observation after baseline)
measure: The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1
timeFrame: Baseline and 1 week following the start of study drug administration
measure: The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2
timeFrame: Baseline and 2 weeks following the start of study drug administration
measure: The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3
timeFrame: Baseline and 3 weeks following the start of study drug administration
measure: The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4
timeFrame: Baseline and 4 weeks following the start of study drug administration
measure: The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6
timeFrame: Baseline and 6 weeks following the start of study drug administration
measure: The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8
timeFrame: Baseline and 8 weeks following the start of study drug administration
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Research Group
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc
state: Alabama
city: Escondido
country: United States
facility: Synergy Clinical Research Center
state: California
city: Lafayette
country: United States
facility: Bay Area Research Institute
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Pico Rivera
country: United States
facility: CNRI Los Angeles LLC
state: California
city: Riverside
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Inst
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Lauderhill
country: United States
facility: Fidelity Clinical Research
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Clinical Research
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Skokie
country: United States
facility: Psychiatric Medicine Associates
state: Illinois
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Clementon
country: United States
facility: CNS Research Institute
state: New Jersey
city: Brooklyn
country: United States
facility: Behavioral Medical Research of Brooklyn
state: New York
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: New York
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Raleigh
country: United States
facility: Richard Weisler, MD and Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Clinical Trials, Inc.
state: North Carolina
city: Cleveland
country: United States
facility: Mood Disorders Program
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Dubois
country: United States
facility: Dubois Regional Medical Center - Behavioral Health Services
state: Pennsylvania
city: Norristown
country: United States
facility: Keystone Clinical Studies LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Bellaire
country: United States
facility: Claghorn-Lesem Research Clinic, LTD
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Eastside Therapeutic Resource
state: Washington
city: Burgas
country: Bulgaria
facility: Call For Information
city: Plovdiv
country: Bulgaria
facility: Call For Information - Center Site #2
city: Plovdiv
country: Bulgaria
facility: Call For Information
city: Sofia
country: Bulgaria
facility: Call For Information - Center Site #2
city: Sofia
country: Bulgaria
facility: Call For Information
city: Budapest
country: Hungary
facility: Call For Information
city: Nagykálló
country: Hungary
facility: Call For Information
city: Bucuresti
country: Romania
facility: Call For Information
city: Bucuresti
country: Romania
facility: Call For Information
city: Bucuresti
country: Romania
facility: Call For Information - Center Site #2
city: Bucuresti
country: Romania
facility: Call For Information
city: Pitesti
country: Romania
facility: Call For Information
city: Targoviste
country: Romania
facility: Call For Information
Study officials:
References:
citation: Calabrese JR, Ketter TA, Youakim JM, Tiller JM, Yang R, Frye MA. Adjunctive armodafinil for major depressive episodes associated with bipolar I disorder: a randomized, multicenter, double-blind, placebo-controlled, proof-of-concept study. J Clin Psychiatry. 2010 Oct;71(10):1363-70. doi: 10.4088/JCP.09m05900gry. Epub 2010 Jul 27.