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

This study has been completed.
Information provided by:
Validus Pharmaceuticals Identifier:
First received: September 6, 2005
Last updated: November 1, 2007
Last verified: June 2006

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

Condition Intervention Phase
Bipolar Disorder
Drug: Extended-release carbamazepine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder

Further study details as provided by Validus Pharmaceuticals:

Primary Outcome Measures:
  • Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment

Secondary Outcome Measures:
  • YMRS Scale
  • Clinical Global Impressions Scale - Bipolar Version
  • HAM-D and MADRS Scales for Depression

Estimated Enrollment: 50
Study Start Date: February 2005
Estimated Study Completion Date: October 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided Identifier: NCT00150605     History of Changes
Other Study ID Numbers: SPD417-308
Study First Received: September 6, 2005
Last Updated: November 1, 2007
Health Authority: United States: Food and Drug Administration processed this record on March 26, 2015