Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Armodafinil; Placebo
Intervention description: Armodafinil tablets, taken orally, once daily in the morning; Matching placebo tablets, taken orally, once daily in the morning
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder

Summary:

      The primary objective of the study is to determine whether armodafinil treatment, at a dosage
      of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood
      stabilizers for treatment of adults with major depression associated with bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a diagnosis of bipolar I disorder according to Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR)
             criteria and is currently experiencing a major depressive episode.

          -  Documentation that the patient has had at least 1 previous manic or mixed episode.

          -  The patient has had no more than 6 mood episodes in the last year.

          -  The patient's current major depressive episode must have started no less than 2 weeks
             and no more than 12 months prior to the screening visit. The current depressive
             episode must have begun after the patient's current mood stabilizer regime began.

          -  The patient must have been taking 1 (or 2) of the following protocol-allowed mood
             stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine,
             quetiapine, risperidone, ziprasidone (only if taken in combination with lithium,
             valproic acid, or lamotrigine). The following criteria must also be met:

               1. The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of
                  the major depressive episode and still be taken at the time of the screening
                  visit at dose or blood level considered appropriate for maintenance therapy by
                  the patient's physician.

               2. The patient must continue to take the same mood stabilizer(s) during the
                  screening period; no mood stabilizer may be added during the screening period.

               3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to
                  the baseline visit.

               4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks
                  prior to the baseline visit.

               5. The mood stabilizer(s) must be taken in an oral formulation, with the exception
                  of risperidone, which can be either in an oral or long-acting injection
                  formulation.

               6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the
                  drugs is lithium, valproic acid, or lamotrigine.

        Exclusion Criteria:

          -  The patient has any Axis I disorder apart from bipolar I disorder that was the primary
             focus of treatment within 6 months of the screening visit or during the screening
             period.

          -  The patient has psychotic symptoms or has had psychosis within 4 weeks of the
             screening visit or during the screening period.

          -  The patient has current active suicidal ideation, is at imminent risk of self-harm, or
             has a history of significant suicidal ideation or suicide attempt at any time in the
             past that causes concern at present.

          -  The patient has a history of an eating disorder or obsessive compulsive disorder (OCD)
             within 6 months of the screening visit or during the screening period.