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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892463
• Other study ID #: D1443L00072
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2009
• Last updated: July 27, 2011
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

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