Expired Study
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Clinical Trial 15336

Riverside, CA 92506

Study Summary:

A double-blind, placebo-controlled, parallel-group, fixed-dosage study to evaluate the efficacy and safety of armodafinil treatment (150 and 200 mg/Day) as adjunctive therapy in adults With Major Depression Associated With Bipolar I Disorder.

Qualified Participants Must:

• Be between 18 and 65 years of age
• Have a diagnosis of bipolar I disorder according to DSM-IV-TR criteria and is currently experiencing a major depressive episode
• Have documentation of at least 1 previous manic or mixed episode
• Have 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
• Have had the current depressive episode begin after the current mood stabilizer regime began
• Have been taking 1 (or 2) of the following protocol-allowed mood stabilizers
• Lithium
• valproic aci
• lamotrigine
• aripiprazole
• olanzapine
• risperidone
• ziprasidone (only if taken in combination with lithium or valproic acid)
• Obtain written informed consent
• Be in good health

Qualified Participants May Receive:

Study Medication and all study related visits at no cost. In addition, possible compensation for each completed visit.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.