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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Quetiapine (Seroquel) XR
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, Seroquel XR, Quetiapine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sunnybrook Health Sciences Centre

Outcomes

Primary Outcome Measures

The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report)

Secondary Outcome Measures

HADS (Hamilton Anxiety Depression Scale) VADIS

Full Information

First Posted
April 30, 2009
Last Updated
July 27, 2011
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00892463
Brief Title
Identifying Very Early Response to Seroquel Extended Release (XR) Augmentation for Major Depressive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depressive Disorder, Seroquel XR, Quetiapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine (Seroquel) XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
50mg/day - first 2 weeks 150mg/day - remaining 4 weeks min dose: 50mg/day max dose: 300mg/day
Primary Outcome Measure Information:
Title
The QIDS-SR16 (Quick Inventory of Depressive Symptomatology - Self-report)
Time Frame
Once Daily for 6 weeks
Secondary Outcome Measure Information:
Title
HADS (Hamilton Anxiety Depression Scale) VADIS
Time Frame
Once/twice Daily for 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayal Schaffer, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre - University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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

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