An 8 Week Study to Evaluate Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder - Tabular View

Tracking Information
First Received Date ^ICMJE	May 30, 2007
Last Updated Date	March 16, 2009
Start Date ^ICMJE	May 2007
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 16, 2009)	Determine if armodafinil treatment is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder, as assessed by the IDS-C30. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: December 20, 2007)	Determine if armodafinil treatment is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder, as assessed from IDS-C30. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00481195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 7, 2008)	MADRS, QIDS-SR16, Q-LES-Q-SF, HAM-A, CGI-BP [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: No ] YMRS [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: December 20, 2007)	MADRS, QIDS-SR16, Q-LES-Q-SF, HAM-A, CGI-BP [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Descriptive Information
Brief Title ^ICMJE	An 8 Week Study to Evaluate Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bipolar I Depression
Intervention ^ICMJE	Drug: Armodafinil
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	264
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.)
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Bulgaria, Hungary, Romania

Administrative Information
NCT ID ^ICMJE	NCT00481195
Responsible Party	Sponsor's Medical Expert, Cephalon
Study ID Numbers ^ICMJE	C10953/2032/DP/US
Study Sponsor ^ICMJE	Cephalon
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cephalon
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP