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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study is currently recruiting participants.

Study NCT00481195. Last updated on November 14, 2008. Information provided by Cephalon

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

An 8 Week Study to Evaluate 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

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 ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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, and at Intermediate Points ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Bipolar I Depression

Intervention ^†

Drug: Armodafinil

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

240

Start Date ^†

May 2007

Completion Date

December 2008

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: lamotrigine, 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 and caffeine 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

Contacts ^††

Contact: Cephalon, Inc. Contact

1-877-CEPHTRY

Location Countries ^†

United States, Bulgaria, Hungary, Romania

Administrative Information Fields

NCT ID ^†

NCT00481195

Organization ID

C10953/2032/DP/US

Secondary IDs ^††

Study Sponsor ^†

Cephalon

Collaborators ^††

Investigators ^†

Information Provided By

Cephalon

Verification Date

November 2008

First Received Date ^†

May 30, 2007

Last Updated Date

November 14, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.