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OpenTrials
Completed

NCT Number: NCT00150605

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

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

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended-release carbamazepine

Drug

Primary outcomes

  1. Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment

Secondary outcomes

  1. YMRS Scale

  2. Clinical Global Impressions Scale - Bipolar Version

  3. HAM-D and MADRS Scales for Depression

Sponsors and collaborators

Lead sponsor

Validus Pharmaceuticals

Industry

Registry information

Official study title

A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder

Important dates

Study start
2005
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Nov 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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