Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Condition: Bipolar I Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Armodafinil; Placebo
Intervention description: Patients were randomly assigned to begin oral treatment with armodafinil, which was titrated to 150 mg/day (3 tablets). Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.; Patients were randomly assigned to begin oral treatment with placebo, which was titrated to 3 tablets. Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.)