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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: Quetiapine (Seroquel) XR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Outpatient status 17-item Hamilton Depression Rating Scale (HAM-D) score of ≥ 18 Treatment with any of the following antidepressant medications for the past 4 weeks at a minimum therapeutic dose Exclusion Criteria: Diagnosis of a past or current bipolar disorder Current psychotic symptoms Substance-induced mood disorder Substance or alcohol dependence Prominent current suicidal ideation as defined by a HAM-D item 3 (suicide item) score of ≥ 3 Current treatment with more than one antidepressant medication Current treatment with an tricyclic (TCA) antidepressant or monoamine oxidase inhibitor (MAOI) A patient with Diabetes Mellitus (DM)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine (Seroquel) XR|50mg/day - first 2 weeks 150mg/day - remaining 4 weeks min dose: 50mg/day max dose: 300mg/day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report) |  | Once Daily for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HADS (Hamilton Anxiety Depression Scale) VADIS |  | Once/twice Daily for 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Seroquel XR, Quetiapine