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Seroquel in Bipolar Depression Versus Lithium

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206141
First received: September 13, 2005
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206141

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov 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
depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013