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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: AstraZeneca
• Treatments: Quetiapine Fumarate

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)