Clinical trial NCT00277654 (phase 3, status: completed)
Conditions: bipolar disorder, anxiety disorder
ICD codes: F31.81, F31.89, F31.9, F25.0, F31.0, F31.31, F31.32, F41.1, F41.9, F40.9, F43.22, F41.0, F93.0, F12.980
Drugs: risperidone
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 lifetime bipolar I, II, or NOS disorder as defined by Diagnostic
             and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.

          3. Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as
             defined by DSM-IV criteria (except clause "does not occur exclusively during a mood
             disorder" of Criterion F for GAD) .

          4. Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP
             < 4.

          5. Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4.

          6. Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or
             anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine
             or depot antipsychotics should be off these medications for > four weeks prior to
             baseline.

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

          8. If female, subjects must be:

               -  postmenopausal,

               -  surgically incapable of childbearing,

               -  or practicing medically acceptable effective method(s) of contraception (e.g.,
                  hormonal methods, barrier methods, intrauterine device) for at least one month
                  prior to study entry and throughout the study.

        Exclusion Criteria:

          1. Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision)
             criteria.

          2. Subjects who do not have lifetime panic disorder or generalized anxiety disorder by
             DSM-IV-TR criteria.

          3. 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.

          4. Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP >
             5).

          5. Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3).

          6. Subjects with clinically significant suicidal or homicidal ideation.

          7. Subjects with current psychotic symptoms.

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

          9. 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.

         10. Subjects with a clinically significant abnormality in their prestudy physical exam,
             vital signs, EKG, or laboratory tests.

         11. Subjects who are allergic to or who have demonstrated hypersensitivity to risperidone.

         12. Women who are pregnant or nursing.

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

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