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OpenTrials
Completed

NCT Number: NCT00150553

Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

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.

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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
  • 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

Treatment and study plan

Extended-release carbamazepine

Drug

Primary outcomes

  1. Score on Young Mania Rating Scale (YMRS) at 12 weeks

Secondary outcomes

  1. Time to remission

  2. Clinical Global Impressions Scale - Bipolar Version

  3. HAM-D and MADRS scales for depression

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Validus Pharmaceuticals

Industry

Registry information

Official study title

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

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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