Clinical trial NCT00277667 (phase 3, status: completed)
Conditions: bipolar disorder
ICD codes: F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32
Drugs: quetiapine
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must be 18 years of age or older.

          2. Subjects must have bipolar I, II, or not otherwise specified (NOS) disorder as defined
             by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
             Revision (DSM-IV-TR) criteria. Of note, bipolar NOS disorder will include subjects
             with either recurrent or sporadic brief hypomanias (hypomanias of 1 to 3 days in
             duration).

          3. Subjects must have moderate-to-severe hypomanic symptoms or mild manic symptoms that
             must be clinically significant (at least mild) but no worse than moderately severe,
             defined as a CGI-BP scale for mania > 3 and < 5, on at least 2 assessment days at
             least 3 days apart during the screening phase.

          4. Subjects must not be receiving mood stabilizing, antidepressant, or antipsychotic
             medication for > one week.

          5. Subjects or their legally authorized representative must sign the Informed Consent
             document after the nature of the trial has been fully explained.

          6. If female, subjects must be: postmenopausal, surgically incapable of childbearing, or
             practicing medically acceptable, effective method(s) of contraception (e.g., hormonal
             methods, intrauterine device) for at least one month prior to study entry and
             throughout the study.

        Exclusion Criteria:

        Criteria for exclusion from this study will be any of the following:

          1. Subjects who do not have bipolar disorder by DSM-IV-TR criteria.

          2. Subjects who are receiving treatment with an antimanic or mood stabilizing medication
             (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators'
             judgment, require ongoing treatment with that medication.

          3. Subjects whose bipolar manic symptoms are presently less than mild (CGI-BP < 2) or
             more than markedly ill (CGI-BP > 5 or YMRS > 21)

          4. Subjects who have severe depressive symptoms (IDS > 39 ) or psychotic features (as
             defined in DSM-IV)

          5. Subjects with clinically significant suicidal or homicidal ideation.

          6. Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or
             other cognitive disorders; a DSM-IV diagnosis of a substance use disorder within the
             past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or
             schizoaffective disorder).

          7. Subjects with serious general medical illnesses including hepatic, renal, respiratory,
             cardiovascular, endocrine, neurologic, or hematologic disease as determined by the
             clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism
             unless stabilized on thyroid replacement > 3 months.

          8. Subjects who are allergic to or who have demonstrated hypersensitivity to quetiapine.

          9. Women who are pregnant or nursing.

         10. Subjects who have received an experimental drug or used an experimental device within
             30 days.

         11. Subjects who have a history of neuroleptic malignant syndrome.