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

NCT00892463 | Completed Phase 4

• 1 other identifier: D1443L00072
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder; Seroquel XR; Quetiapine

Outcome Measures

Primary Outcomes (1)

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

  Once Daily for 6 weeks

Secondary Outcomes (1)

• HADS (Hamilton Anxiety Depression Scale) VADIS

  Once/twice Daily for 6 weeks

Interventions

Quetiapine (Seroquel) XR DRUG

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

Also known as: Seroquel XR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• AstraZeneca: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ayal Schaffer, MD

  Sunnybrook Health Sciences Centre - University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 4, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

CA (1)