双向障碍1.ppt

* FDA-approved Indications of Agents Used in the Treatment of Adults with Bipolar Disorder (Note: this is a slide build.) This slide is based on FDA-approved labeling for all FDA-approved treatments for bipolar depression, bipolar mania, and mixed states for either acute or maintenance treatment. As you can see from this chart, most FDA-approved therapies for bipolar disorder are not indicated for depressive episodes. The olanzapine/fluoxetine combination (OFC) is approved for treatment of acute bipolar depression. SEROQUEL? (quetiapine fumarate) is FDA-approved as monotherapy for treatment of acute mania and for acute bipolar depression. It is important to note the clinical trials which supported the approval of SEROQUEL as adjunct maintenance treatment of bipolar disorder enrolled patients whose most recent episode was manic, depressed, or mixed. The most recent FDA approval of SEROQUEL makes it the only agent proven effective for both acute bipolar depression and maintenance treatment, as adjunct to lithium or divalproex, of bipolar depression. With the exception of the olanzapine/fluoxetine combination, SSRIs are not FDA approved for the treatment of any phase of bipolar disorder. Note: The immediate release formulations of divalproex and carbamazepine are not approved for bipolar disorder. This chart does not imply comparable efficacy or safety profiles. Background Information for Speakers: Maintenance treatments were defined based on FDA approved Indication language in the respective product’s Prescribing Information. In instances where the approved language was not specific to maintenance treatment of mania, depression, or mixed episodes, the Clinical Trials section was utilized to identify the specific patient population(s) that were included in the clinical trials conducted to support that products maintenance treatment indication. In instances where the approved indication language was not specific to maintenance treatment of mania, depression, or mixed