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Sponsored by: |
Cephalon |
Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00481195 |
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.
Condition | Intervention | Phase |
Bipolar I Depression |
Drug: Armodafinil |
Phase II |
MedlinePlus related topics: | Depression |
ChemIDplus related topics: | Armodafinil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 240 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
Drug: Armodafinil
Patients will begin oral treatment with armodafinil or placebo, which will be titrated to 150 mg/day (3 tablets) of the randomly assigned study drug (armodafinil or placebo).
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: Cephalon, Inc. Contact | 1-877-CEPHTRY |
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Show 55 Study Locations |
Cephalon |
Responsible Party: | Cephalon ( Sponsor's Medical Expert ) |
Study ID Numbers: | C10953/2032/DP/US |
First Received: | May 30, 2007 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00481195 |
Health Authority: | United States: Food and Drug Administration |
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