Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Cephalon

Status and phase: Completed; Phase 2

Conditions: Bipolar I Depression

Treatments: Drug: Placebo; Drug: Armodafinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481195

C10953/2032/DP/US

Details and patient eligibility

About

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.

Enrollment: 257 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 (Any woman becoming pregnant during the study will be withdrawn from the study.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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257 participants in 2 patient groups, including a placebo group

Armodafinil

Active Comparator group

Treatment:

Drug: Armodafinil

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo