Clinical trial NCT00232414 (phase 3, status: completed)
Conditions: bipolar i disorder
ICD codes: F31.70, F31.71, F31.72, F31.73, F31.74, F31.75, F31.76
Drugs: quetiapine
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, subjects must meet the following criteria:

          1. Male or female patients, 12-18 years of age.

          2. Female patients of menarche must be using a medically accepted means of contraception
             (e.g. oral contraceptives, Depo-Provera, abstinence).

          3. Each patient's authorized legal guardian must understand the nature of the study and
             must provide written informed consent. Each patient must also give assent to study
             participation.

          4. Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (DSM-IV) BP, type I and currently display an acute
             depressive episode as determined by K-SADS (Geller et al 2000).

          5. Patients must have a baseline (day 0) CDRS score of at least 40.

          6. Subjects should be fluent in English.

        Exclusion Criteria:

        Patients will be excluded from the protocol for any of the following reasons:

          1. Female patients who are either pregnant or lactating.

          2. Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory,
             cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical
             conditions.

          3. Any history of current or past diabetes that was treated with pharmacological
             intervention.

          4. Neurological disorders including epilepsy, stroke, or severe head trauma.

          5. Clinically significant laboratory abnormalities, on any of the following tests: CBC
             with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid
             profile, fasting glucose, urinalysis, thyroid indices and EKG.

          6. Depression due to a general medical condition or substance-induced depression
             (DSM-IV).

          7. Mental retardation (IQ <70).

          8. YMRS score of > 12.

          9. History of hypersensitivity to or intolerance of quetiapine.

         10. Prior history of quetiapine non-response.

         11. DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.

         12. Judged clinically to be at suicidal risk (defined as having active suicidal ideation,
             intent or plan, or a serious suicide attempt within 30 days, or a baseline CDRS
             suicide score of > 3).

         13. Participation in a clinical trial of another investigational drug within 1 month (30
             days) prior to study entry.

         14. Treatment with an injectable depot neuroleptic within less than one dosing interval
             between depot neuroleptic injections and day 0.

         15. Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except
             as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.

         16. Patient who were treated with carbamazepine at any point during the month prior to
             screening.

         17. Schizophrenia or other psychotic disorders (including schizophreniform disorder,
             schizoaffective disorder, delusional disorder, brief psychotic disorder, shared
             psychotic disorder, psychotic disorder due to a general medical condition,
             substance-induced psychotic disorder, psychotic disorder not otherwise specified) as
             defined in the DSM-IV.

         18. Major depressive disorder, dysthymic disorder, depressive disorder not otherwise
             specified.

         19. Subjects who are not fluent in English.