Seroquel in Bipolar Depression Versus SSRI

Brief Summary

Official Title: “Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)”

The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Interventions Used in this Clinical Trial

  • Drug: quetiapine fumarate (Seroquel)
  • Drug: paroxetine
  • Behavioral: mood stabilizing activity

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Measures

  • Secondary variables supportive to the primary objective:
  • MADRS total score response
  • MADRS total score remission

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Male and female out-patients aged 18 to 65 years inclusive
  • Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed

Exclusion Criteria

  • Current period of depression lasting less than 4 weeks or more than 12 months
  • Use of prohibited medication
  • Substance or alcohol dependence or abuse
  • Current suicide risk or suicide attempt within 6 months
  • Breast feeding or pregnancy
  • Clinically relevant disease or clinical finding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • AstraZeneca
  • Overall Official(s)
    • AstraZeneca Seroquel Medical Science Director, MD, Study Director, AstraZeneca

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00119652