Depressive Disorder, Major Clinical Trial
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
Verified date | July 2011 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | AstraZeneca |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report) | Once Daily for 6 weeks | No | |
Secondary | HADS (Hamilton Anxiety Depression Scale) VADIS | Once/twice Daily for 6 weeks | No |
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