Seroquel in Bipolar Depression Versus Lithium

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 13, 2005
Last updated: January 3, 2013
Last verified: January 2013
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 Intervention Phase
Bipolar Disorder
Bipolar Depression
Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • MADRS total score response
  • MADRS total score remission

Estimated Enrollment: 672
Study Start Date: August 2005
Study Completion Date: May 2007

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00206141

  Show 76 Study Locations
Sponsors and Collaborators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00206141     History of Changes
Other Study ID Numbers: D1447C00001  EMBOLDEN I 
Study First Received: September 13, 2005
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health

Keywords provided by AstraZeneca:
Bipolar disorder
bipolar depression

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on February 11, 2016