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Quetiapine Extended Release (XR) Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder (MDD/GAD)
This study is currently recruiting participants.
Verified by University Hospital Case Medical Center, May 2009
First Received: March 24, 2009   Last Updated: May 4, 2009   History of Changes
Sponsors and Collaborators: University Hospital Case Medical Center
AstraZeneca
Information provided by: University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT00868374
  Purpose

The primary objective is to test the hypothesis that quetiapine XR (Extended Release) monotherapy or adjunctive therapy to antidepressant is superior to placebo monotherapy or placebo adjunctive therapy to antidepressant(s) in the acute treatment of depression symptoms in patients with MDD and comorbid GAD. The secondary objectives are to test the hypotheses that quetiapine XR is superior to placebo in the reduction of anxiety symptoms in patients with major depressive disorder and comorbid generalized anxiety disorder, the improvement of the quality of sleep in patients with major depressive disorder and comorbid generalized anxiety disorder and the improvement of the quality of life in patients with major depressive disorder and comorbid generalized anxiety disorder.


Condition Intervention Phase
Major Depressive Disorder
Generalized Anxiety Disorder
Drug: Quetiapine XR
Drug: Placebo
Phase III

MedlinePlus related topics: Antidepressants Anxiety Depression
Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Quetiapine XR Monotherapy or Adjunctive Therapy to Antidepressants in the Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Quetiapine XR
Drug: Quetiapine XR
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
2: Placebo Comparator Drug: Placebo
Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide informed consent before beginning any study-specific procedures
  • Male and female patients at least 18 years of age - 70 years of age
  • Meets DSM-IV criteria for MDD, currently depressed
  • DSM-IV diagnosis of current GAD
  • Women with reproductive potential must have a negative urine pregnancy test

Exclusion Criteria:

  • Patients who have had a current episode of depression for less than 4 weeks from enrollment
  • Patients who have been treated for their current depressive episode for more than 3 weeks with Quetiapine therapy 50 mg/day
  • Patients currently taking antidepressants known to cause somnolence/sedation such as mirtazapine or unable to wean off current antidepressant if they choose monotherapy
  • Patients who meet DSM-IV criteria for substance dependence confirmed by the Substance Use Disorder Module of the Structured Clinical Interview for DSM-IV (SCID), for any substance except for caffeine and nicotine, with substance abuse within last 3 months or substance dependence within last 6 months;
  • Concurrent obsessive-compulsive disorder
  • Patients with a history of clinically significant cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease, or other disease or clinical finding that is unstable or that, in the opinion of the investigator, would be negatively effected by trial medication or that would effect trial medication
  • A patient with diabetes mellitus (DM) fulfilling one of the following criteria:

    • Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) > 8.5%
    • Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks
    • Not under physician care for DM
    • Physician responsible for patient's DM care has not indicated that the patient's DM is controlled
    • Physician responsible for patient's DM care has not approved the patient's participation in the study
    • Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization (for thiazolidinediones (glitazones) this period should not be less than 8 weeks before randomization)
    • Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks

Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study. A patient could be enrolled at a later time if DM is stabilized.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868374

Contacts
Contact: Elizabeth Fein, MA 216-844-2863 elizabeth.fein@UHhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Liz Fein, MA     216-844-2863     elizabeth.fein@UHhospitals.org    
Principal Investigator: Keming Gao, MD, PhD            
Sponsors and Collaborators
University Hospital Case Medical Center
AstraZeneca
Investigators
Principal Investigator: Keming Gao, MD, PhD University Hospitals Case Medical Center
  More Information

No publications provided

Responsible Party: University Hospital Case Medical Center ( Keming Gao, MD, PhD )
Study ID Numbers: 12-07-29
Study First Received: March 24, 2009
Last Updated: May 4, 2009
ClinicalTrials.gov Identifier: NCT00868374     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Depression
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents
Behavioral Symptoms
Quetiapine
Anxiety Disorders
Mental Disorders
Mood Disorders
Antidepressive Agents

Additional relevant MeSH terms:
Depression
Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents
Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009