Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Validus Pharmaceuticals
• Treatments: Carbamazepine; Psychotropic Drugs

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