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

Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: Quetiapine (Seroquel) XR (Drug)

Phase: Phase 4

Status: Completed

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

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: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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

Starting date: May 2009
Last updated: July 27, 2011

Page last updated: August 23, 2015

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