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

Validus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Extended-release carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150605

SPD417-308

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)