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Completed

NCT Number: NCT00119652

Seroquel in Bipolar Depression Versus SSRI

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.

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Key information

Conditions

Bipolar Disorder Behavior Behavioral Symptoms Bipolar Depression Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

quetiapine fumarate (Seroquel)

Drug

paroxetine

Drug

mood stabilizing activity

Behavioral

Primary outcomes

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

Secondary outcomes

  1. Secondary variables supportive to the primary objective:

  2. MADRS total score response

  3. MADRS total score remission

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: EMBOLDEN II

Important dates

Study start
2005
Study completion
2007
First posted
Jul 14, 2005
Registry last updated
Jan 4, 2013

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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