Seroquel in Bipolar Depression Versus Lithium - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206141

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 III

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Quetiapine Quetiapine fumarate

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

Study ID Numbers:	D1447C00001, EMBOLDEN I
Study First Received:	September 13, 2005
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00206141 History of Changes
Health Authority:	United States: Food and Drug Administration; Ukraine: Ministry of Health

Keywords provided by AstraZeneca:

Bipolar disorder
bipolar depression
depression

Study placed in the following topic categories:

Depression
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Lithium Carbonate
Depressive Disorder
Antipsychotic Agents

Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Mood Disorders
Psychotic Disorders
Lithium

Additional relevant MeSH terms:

Depression
Tranquilizing Agents
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009