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Seroquel in Bipolar Depression Versus Lithium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206141
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 4, 2013
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Brief Summary:
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Bipolar Depression Depression Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
Study Start Date : August 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Secondary Outcome Measures :
  1. MADRS total score response
  2. MADRS total score remission

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.

Exclusion Criteria:

  • Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
  • History of non-response to an adequate treatment
  • Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
  • Pregnancy or lactation
  • Clinically relevant disease or clinical finding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206141

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Sponsors and Collaborators
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Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00206141    
Other Study ID Numbers: D1447C00001
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Bipolar disorder
bipolar depression
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs