Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Armodafinil
Intervention description: Armodafinil tablets, taken orally, once daily in the morning
Intervention MeSH terms: Modafinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 867.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of long term
      (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in
      adults with bipolar I disorder.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3,
             double-blind study of armodafinil treatment in patients with major depression
             associated with bipolar I disorder.

          -  The patient met criteria for enrollment in the previous double-blind study and, in the
             opinion of the investigator, is in need of continued treatment for depression.

          -  During the previous double-blind study, the patient must have been taking 1 (or 2) of
             the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine;
             quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in
             combination with lithium, valproic acid, or lamotrigine). The following criteria must
             also be met:

               1. The mood stabilizers must be taken in an oral formulation, with the exception of
                  risperidone, which can be either in an oral or long-acting injection formulation.

               2. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the
                  drugs is lithium, valproic acid, or lamotrigine.

               3. The patient must be judged by the investigator to be compliant with treatment
                  with the mood stabilizer(s).

               4. The patient must be willing to continue treatment with the same protocol-allowed
                  mood stabilizer(s) at dosages considered appropriate by the investigator.

          -  The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the
             enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed
             with the medical monitor to determine their suitability for enrollment.

        Key Exclusion Criteria:

          -  The patient has any Axis I or Axis II disorder apart from bipolar I disorder that
             became the primary focus of treatment during the double-blind study.

          -  The patient has psychotic symptoms or had psychosis during the double-blind study.

          -  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 met criteria for alcohol or substance abuse or dependence (with the
             exception of nicotine dependence) during the double-blind study.

          -  The patient has any history of homicidal ideation or significant aggression or
             currently has homicidal or significant aggressive ideation.