Study to Evaluate the Efficacy and Safety 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; Placebo
Intervention description: Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.; Matching Placebo, also in tablet form 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: 492.0
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,
             risperidone, or ziprasidone (only if taken in combination with lithium or valproic
             acid).

          -  Written informed consent is obtained.

          -  The patient is a man or woman 18 through 65 years of age.

          -  The patient is in good health (except for diagnosis of bipolar I disorder) as judged
             by the investigator, on the basis of medical and psychiatric history, medical
             examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis.

          -  Women of childbearing potential (women who have not reached menopause, women who are
             less than 2 years postmenopausal, and women who are not surgically sterile) who are
             sexually active must use a medically accepted method of contraception and must agree
             to continue use of this method for the duration of the study and for 30 days after
             participation in the study.

          -  The patient is willing and able to comply with study restrictions and to attend
             regularly scheduled clinic visits as specified in this protocol.

          -  The patient has permanent accommodations and means of being contacted by the study
             center.

          -  The patient understands that they may enroll in this clinical study only once and may
             not enroll in any other clinical study while participating in this trial.

        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.

          -  The patient has a history of alcohol or substance abuse or dependence (with the
             exception of nicotine dependence) within 3 months of the screening visit or during the
             screening period.

          -  The patient has a history of any cutaneous drug reaction or drug hypersensitivity
             reaction, a history of any clinically significant hypersensitivity reaction, or a
             history of multiple clinically relevant allergies.

          -  The patient has any clinically significant uncontrolled medical condition, treated or
             untreated.

          -  The patient has received modafinil or armodafinil within the past 5 years, or the
             patient has a known sensitivity to any ingredients in the study drug tablets.

          -  The patient has previously participated in a clinical study with armodafinil or has
             used any investigational product within 90 days of screening. The patient may not
             enroll in any other clinical study while participating in this study.

          -  The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain
             stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or
             repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening
             visit.

          -  The patient is a pregnant or lactating woman.