NCT00892463

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Quetiapine (Seroquel) XR	50mg/day - first 2 weeks 150mg/day - remaining 4 weeks min dose: 50mg/day max dose: 300mg/day

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-05-04
• Last updated: 2011-07-28

Locations

1 site across 1 country: Canada