Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: quetiapine SR; quetiapine sr placebo
Intervention description: quetiapine SR, dose range 200-600mg, each night QHS for 6mos; quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: bipolar disorder, mania, depression

Summary:

      To assess the acute and long-term bimodal efficacy of QTP, 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female;

          -  Age 18 years and older

          -  Patients on:

               -  Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5
                  mEq/l OR

               -  DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR

               -  LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR

               -  Any combination 3a, 3b, or 3c

          -  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

          -  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

          -  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 ;

          -  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:

          -  Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder,
             schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or
             AIDS induced mania

          -  Women with a positive pregnancy test or who are lactating

          -  Women of child-bearing potential who are not practicing a clinically accepted method
             of contraception

          -  Patients with general medical conditions that contraindicate psychoactive medications
             or uncontrolled medical disorder or central nervous system diseases.

          -  Patients whose clinical status requires inpatient or day hospital treatment

          -  History of severe side effects associated with therapeutic doses of Li, DIV, LAM

          -  Alcohol or drug dependent at time of enrollment

          -  Suicidal at time of enrollment.

          -  Current or previous exposure to QTP