Seroquel in Bipolar Depression Versus SSRI

Condition(s) targeted: Bipolar Disorder; Bipolar Depression; Depression

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

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

Secondary variables supportive to the primary objective:

MADRS total score response

MADRS total score remission

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Research Site, Santiago, Chile

Research Site, Providencia Santiago, Chile

Research Site, Bogota, Colombia

Research Site, San Jose, Costa Rica

Research Site, Tripoli, Greece

Research Site, Athens, Greece

Research Site, Thessaloniki, Greece

Research Site, Mexico, Mexico

Research Site, Yucatan, Mexico

Research Site, Lima, Peru

Research Site, SAN BORJA, Peru

Research Site, Iasi, Romania

Research Site, Bucharest, Romania

Research Site, Galati, Romania

Research Site, MAGURA, Romania

Research Site, BENONI, South Africa

Research Site, Pretoria, South Africa

Research Site, Durban, South Africa

Research Site, Cape Town, South Africa

Research Site, Istanbul, Turkey

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Research Site, Southport, Queensland, Australia

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AstraZeneca Clinical Trial Information - Outside US

Starting date: May 2005
Ending date: July 2007
Last updated: November 2, 2007