The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Extended-release carbamazepine	Phase III

Further Study Details: 

Primary Outcomes: Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
Secondary Outcomes: YMRS Scale; Clinical Global Impressions Scale - Bipolar Version; HAM-D and MADRS Scales for Depression
Expected Total Enrollment:  50

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• DSM-IV criteria for Bipolar I disorder
• Screening YMRS score =>16
• Women of childbearing potential agree to take adequate precautions against contraception
• Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic

Exclusion Criteria:

• Hospitalization required for treatment of psychiatric symptoms
• Patients who meet DSM-IV for ultra-rapid cycling
• History of serious suicide attempt requiring medical intervention
• Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening

Study ID Numbers:  SPD417-308
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00150605
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13