Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With 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

NCT00150553

SPD417-306

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSM-IV criteria for bipolar I disorder
• Screen YMRS score => 16
• Women of childbearing potential agree to take adequate precautions against contraception

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind