Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder
Information source: Validus Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Extended-release carbamazepine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Validus Pharmaceuticals
Summary
The purpose of this study is to evaluate the safety of SPD417 when given with other
psychotropic medications to treat bipolar I disorder.
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
Secondary outcome: YMRS ScaleClinical Global Impressions Scale - Bipolar Version HAM-D and MADRS Scales for Depression
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2005
Ending date: October 2005
Last updated: November 1, 2007
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