Identifying Very Early Response to Seroquel Extended Release (XR) Augmentation for Major Depressive Disorder
Information source: Sunnybrook Health Sciences Centre
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: Quetiapine (Seroquel) XR (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Sunnybrook Health Sciences Centre Official(s) and/or principal investigator(s):
Ayal Schaffer, MD, Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre - University of Toronto
Overall contact:
Catherine Reis, Hon. B.A, Phone: 416.480.6100, Ext: 4092, Email: catherine.reis@sunnybrook.ca
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.
Clinical Details
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 design: Treatment, Single Group Assignment, Efficacy Study
Primary outcome: The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report)
Secondary outcome: HADS (Hamilton Anxiety Depression Scale)
VADIS
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Catherine Reis, Hon. B.A, Phone: 416.480.6100, Ext: 4092, Email: catherine.reis@sunnybrook.ca
Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
Additional Information
Starting date: May 2009
Ending date: July 2010
Last updated: May 1, 2009
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