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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150605
• Other study ID #: SPD417-308
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: November 1, 2007
• Start date: February 2005
• Est. completion date: October 2005

Study information

• Verified date: June 2006
• Source: Validus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Extended-release carbamazepine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Validus Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
Secondary	YMRS Scale
Secondary	Clinical Global Impressions Scale - Bipolar Version
Secondary	HAM-D and MADRS Scales for Depression