Trial | NCT00150553  Report issue

Title

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

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    carbamazepine ...

  • Study Participants

    102
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
2005
Study Completion
Oct 31
2005
Last Update
Nov 02
2007
Estimate

Drug Extended-release carbamazepine

Criteria 

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