Olanzapine Treatment of Patients With Bipolar I Disorder
Condition: Depression, Bipolar
MeSH terms: Bipolar Disorder
Intervention: Olanzapine; Placebo
Intervention description: 5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).; placebo tablets, oral, once daily at bedtime, 6 weeks
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess whether olanzapine is superior to placebo in patients
      with bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Each patient must be reliable, have a level of understanding sufficient to perform all
             tests and examinations required by the protocol, and must understand the nature of the
             study and have provided informed consent

          -  All female patients must test negative for pregnancy and females of breast-feeding
             potential must agree not to breastfeed an infant during the study and for 1 month
             following the last dose of study drug

          -  Patients must fulfill the criteria for a major depressive episode according to the
             Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) as
             well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based
             on clinical assessment and confirmed by the structured diagnostic interview, the Mini
             International Neuropsychiatric Interview (MINI), at study entry

          -  Patients must have a current 17-item Hamilton Depression Rating Scale (HAMD-17) score
             greater than or equal to 18 at Visit 1 and Visit 2

          -  Patients must have a current Young Mania Rating Scale (YMRS) total score less than or
             equal to 8 at Visit 2.

        Exclusion Criteria:

          -  Has received treatment within the past 30 days with a drug (not including study drug)
             that has not received regulatory approval for any indication at the time of study
             entry

          -  Has participated in a clinical trial of another investigational drug, including
             olanzapine, within 1 month (30 days) before study entry

          -  Was previously treated with olanzapine and had bipolar depression considered to be
             treatment-resistant to olanzapine or to olanzapine in combination with an available
             selective serotonin reuptake inhibitor (SSRI)

          -  Is experiencing (at the time of study entry) a current episode of bipolar depression
             that is greater than 90 days in duration

          -  Has been treatment-resistant to any therapy prescribed for bipolar depression when
             olanzapine alone or with an SSRI prescribed at an appropriate dose and duration