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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00892463
Recruitment Status : Completed
First Posted : May 4, 2009
Last Update Posted : July 28, 2011
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Quetiapine (Seroquel) XR Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Intervention Details:
    Drug: Quetiapine (Seroquel) XR
    50mg/day - first 2 weeks 150mg/day - remaining 4 weeks min dose: 50mg/day max dose: 300mg/day
    Other Name: Seroquel XR

Primary Outcome Measures :
  1. The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report) [ Time Frame: Once Daily for 6 weeks ]

Secondary Outcome Measures :
  1. HADS (Hamilton Anxiety Depression Scale) VADIS [ Time Frame: Once/twice Daily for 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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)
  2. Outpatient status
  3. 17-item Hamilton Depression Rating Scale (HAM-D) score of ≥ 18
  4. Treatment with any of the following antidepressant medications for the past 4 weeks at a minimum therapeutic dose

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00892463

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Ayal Schaffer, MD Sunnybrook Health Sciences Centre - University of Toronto

Responsible Party: Dr. Ayal Schaffer, Sunnybrook Health Sciences Centre Identifier: NCT00892463     History of Changes
Other Study ID Numbers: D1443L00072
First Posted: May 4, 2009    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by Sunnybrook Health Sciences Centre:
Major Depressive Disorder
Seroquel XR

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs