Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    carbamazepine ...
  • Study Participants

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.
Study Started
Jan 31
Study Completion
Oct 31
Last Update
Nov 02

Drug Extended-release carbamazepine


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
No Results Posted