Identifying Very Early Response to Seroquel Extended Release (XR) Augmentation for Major Depressive Disorder - Full Text View

Sponsors and Collaborators:	Sunnybrook Health Sciences Centre AstraZeneca
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00892463

Purpose

The proposed study is for a 6 week open-label clinical trial in which Seroquel XR is added to a selective serotonin reuptake inhibitor (SSRI) medication for the treatment of depressive and/or anxiety symptoms. Each subject will self-report changes in symptoms, functional impairment, etc. on a twice daily basis using a handheld computer (HHC) that transmits real-time symptoms reports to a central database. Each subject will be assessed in-person on a weekly or biweekly basis during the course of the study.

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: Quetiapine (Seroquel) XR	Phase IV

MedlinePlus related topics: Anxiety Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Single Group Assignment, Efficacy Study
Official Title:	Enhanced Identification of Very Early Response to Seroquel XR Added to an Antidepressant for the Treatment of Major Depressive Disorder With or Without Generalized Anxiety Disorder

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report) [ Time Frame: Once Daily for 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HADS (Hamilton Anxiety Depression Scale) VADIS [ Time Frame: Once/twice Daily for 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

50mg/day - first 2 weeks 150mg/day - remaining 4 weeks min dose: 50mg/day max dose: 300mg/day

Detailed Description:

This study is a 6-week open-label clinical trial in which Seroquel XR is added to an antidepressant medication for the treatment of MDD with or without comorbid generalized anxiety disorder. Patients who are currently experiencing a depressive episode that has not responded to an adequate trial of an antidepressant will be eligible to participate. During the course of augmentation treatment with Seroquel XR, each subject will regularly enter information on symptom severity and functional impairment into their handheld computer, and this information will be wirelessly transmitted to a central database.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of major depressive disorder, currently depressed with or without a comorbid generalized anxiety disorder as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
Outpatient status
17-item Hamilton Depression Rating Scale (HAM-D) score of ≥ 18
Treatment with any of the following antidepressant medications for the past 4 weeks at a minimum therapeutic dose

Exclusion Criteria:

Diagnosis of a past or current bipolar disorder
Current psychotic symptoms
Substance-induced mood disorder
Substance or alcohol dependence
Prominent current suicidal ideation as defined by a HAM-D item 3 (suicide item) score of ≥ 3
Current treatment with more than one antidepressant medication
Current treatment with an tricyclic (TCA) antidepressant or monoamine oxidase inhibitor (MAOI)
A patient with Diabetes Mellitus (DM)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892463

Contacts

Contact: Catherine Reis, Hon. B.A

416.480.6100 ext 4092

catherine.reis@sunnybrook.ca

Locations

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

AstraZeneca

Investigators

Principal Investigator:

Ayal Schaffer, MD

Sunnybrook Health Sciences Centre - University of Toronto

More Information

No publications provided

Responsible Party:	Sunnybrook Health Sciences Centre ( Dr. Ayal Schaffer )
Study ID Numbers:	D1443L00072
Study First Received:	April 30, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00892463 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:

Major Depressive Disorder
Seroquel XR
Quetiapine

Study placed in the following topic categories:

Depression
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents

Behavioral Symptoms
Quetiapine
Anxiety Disorders
Mental Disorders
Mood Disorders
Antidepressive Agents

Additional relevant MeSH terms:

Depression
Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009