Seroquel in Bipolar Depression Versus SSRI - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00119652

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder Bipolar Depression Depression	Drug: quetiapine fumarate (Seroquel) Drug: paroxetine Behavioral: mood stabilizing activity	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Quetiapine Quetiapine fumarate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Secondary variables supportive to the primary objective:
MADRS total score response
MADRS total score remission

Enrollment:	676
Study Start Date:	May 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119652

Show 55 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):

McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, Agambaram V, Merideth C, Nordenhem A, Young AH; EMBOLDEN II (Trial D1447C00134) Investigators. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010 Feb;71(2):163-74. Epub 2010 Jan 26.

ClinicalTrials.gov Identifier:	NCT00119652 History of Changes
Other Study ID Numbers:	D1447C00134
Study First Received:	July 6, 2005
Last Updated:	March 24, 2009
Health Authority:	United States: Food and Drug Administration

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
Paroxetine
Quetiapine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 24, 2012