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

INTERVENTION: Trade Name: Nuvigil Product Name: Armodafinil Product Code: 10593 Pharmaceutical Form: Tablet INN or Proposed INN: Armodafinil CAS Number: 112111‐43‐0 Current Sponsor code: CEP‐10953 Other descriptive name: R‐modafinil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Major Depression Associated With Bipolar I Disorder Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: Main Objective: 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. Efficacy will be assessed by the mean change from baseline in the total score from the 30 Item Inventory of Depressive Symptomatology–Clinician Rated (IDS C30). Primary end point(s): The primary efficacy measure and endpoint for this study is the IDS C30 assessed at all postbaseline visits. Secondary Objective: • to evaluate the efficacy of armodafinil treatment compared with placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with bipolar I disorder; • to evaluate the change from baseline in the Clinical Global Impression of Severity (CGI‐S) of depression rating for depression at weeks 1, 2, 4, 6, 7 and 8, or last postbaseline observation; • to evaluate the efficacy of armodafinil treatment compared with placebo treatment on patient functioning as assessed by the Global Assessment of Functioning (GAF) Scale scores at weeks 4 and 8, or last postbaseline observation; • to evaluate the safety and tolerability of armodafinil ; ; For full details please refer to the Protocol. Timepoint(s) of evaluation of this end point: minimum 3 months SECONDARY OUTCOME: Secondary end point(s): The secondary efficacy measures and endpoints for this study are as; follows:; • the IDS‐C30 assessed at weeks 1, 2, 4, 6, 7, and 8, or last postbaseline observation; • CGI‐S for depression assessed at weeks 1, 2, 4 , 6, 7, and 8, or last; post baseline observation; • GAF Scale assessed at weeks 4 and 8, or last postbaseline observation Timepoint(s) of evaluation of this end point: 8 weeks INCLUSION CRITERIA: (a)The patient has a diagnosis of bipolar I disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM IV TR) criteria as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition – Clinical Trials (SCID CT) and is currently experiencing a major depressive episode. (b)The investigator has established, by medical record documentation or by history from the patient and at least 1 reliable informant, that the patient has had at least 1 previous manic or mixed episode, which resulted in functional impairment and was treated (or should have been treated) with a mood stabilizer or antipsychotic medication. (c)The patient has had no more than 6 mood episodes in the last year. (d1) 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 depres