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CompletedNCT00892463Updated Jul 28, 2011

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

A Phase 4 interventional study of Quetiapine (Seroquel) XR in Depressive Disorder, Major, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-07-28.

Sponsored by Sunnybrook Health Sciences Centre · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depressive Disorder, Major

Keywords

  • Major Depressive Disorder
  • Seroquel XR
  • Quetiapine
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 26 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Interventions

  • DrugQuetiapine (Seroquel) XR

    50mg/day - first 2 weeks 150mg/day - remaining 4 weeks min dose: 50mg/day max dose: 300mg/day

    Also known as: Seroquel XR

06

What researchers measure

Primary outcomes

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

    Time frame: Once Daily for 6 weeks

Secondary outcomes

  1. HADS (Hamilton Anxiety Depression Scale) VADIS

    Time frame: Once/twice Daily for 6 weeks

07

Study locations

1 site
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00892463
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborators
AstraZeneca
First posted
May 4, 2009
Start date
May 2009
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jul 28, 2011

Study contacts

Ayal Schaffer, MD
principal investigator · Sunnybrook Health Sciences Centre - University of Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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