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Completed

NCT Number: NCT00892463

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

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.

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Key information

Conditions

Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Quetiapine (Seroquel) XR

Drug

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

Other names: Seroquel XR

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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 4, 2009
Registry last updated
Jul 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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