Iloperidone in Mixed States of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: iloperidone
Intervention description: Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.
Intervention MeSH terms: Iloperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mixed episode

Summary:

      1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct to
           ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any
           combination of the three thereof, in a group of patients with an index episode of a
           mixed state in BD.

        2. To assess background, baseline features, and behavioral components which characterize
           treatment response/non-response in the acute and long term management of MS
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female;

          2. Age 18 years and older

          3. Patients on:

               -  Li at a stable dose for 2 weeks or longer, and a serum level at screening of
                  greater than or equal to 0.5 mEq/l OR

               -  DIV dose for 2 weeks or longer, and a serum level at screening of greater than or
                  equal to 45 ug/ml OR

               -  LAM (dosage/day ≥100mg) at a stable dose for 2 weeks or longer OR

               -  Any combination 3a, 3b, or 3c

          4. Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using
             the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7

          5. Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young
             Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale
             (MADRS) score>/=14

          6. Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with
             the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS
             Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ;

          7. Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the
             simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a
             manic/hypomanic episode for at least 2 days with the simultaneous presence of Young
             Mania Rating Scale (YMRS) score>/=14

        Exclusion Criteria:

          1. Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder,
             schizotypal disorder, bipolar disorder with psychotic sub-type that requires
             hospitalization, drug induced mania or AIDS induced mania

          2. Women with a positive pregnancy test or who are lactating

          3. Women of child-bearing potential who are not practicing a clinically accepted method
             of contraception

          4. Patients with general medical conditions that contraindicate psychoactive medications
             or uncontrolled medical disorder or central nervous system diseases.

          5. Patients whose clinical status requires inpatient or day hospital treatment

          6. History of severe side effects associated with therapeutic doses of Li, DIV, LAM

          7. Alcohol or drug dependent at time of enrollment

          8. Suicidal at time of enrollment.

          9. Current or previous exposure to iloperidone

         10. Patients taking medication that cause QTC prolongation

         11. Patients with serious cardiac disease